Self-locking bronchial one-way ventilation valve

Abstract

The present application relates to the technical field of medical devices, in particular to a self-locking bronchial one-way ventilation valve, comprising a flexible connecting piece and self-locking mechanism and one-way ventilation mechanism connected to both ends of the flexible connecting piece. The flexible connecting piece comprises a flexible support and a connecting block, and can self-adaptively adjust the included angle between the supports according to the bifurcation angle of the bronchus. The self-locking mechanism comprises a pressure receiving ring, a telescopic rod, an anchoring plate and a transmission unit, and provides initial anchoring through a spring. When coughing, the transmission mechanism is used to convert the axial impact force into radial pressure force, so as to realize dynamic self-locking. The one-way ventilation mechanism is provided with a one-way valve and an annular sputum discharge channel, and adopts various implementation modes of conical valve, duckbill valve, umbrella valve or one-way valve. While maintaining the one-way ventilation function, the sputum discharge unit is automatically opened to discharge sputum when coughing. The valve uses physiological impact force to enhance the fixing effect, solves the problems of easy displacement of the traditional valve and poor sputum discharge, and significantly improves the safety and effectiveness of lung volume reduction therapy.

Description

Technical Field

[0001] This invention patent relates to the field of medical device technology, and more specifically, to a self-locking bronchial one-way ventilation valve. Background Technology

[0002] Lung volume reduction surgery is an important surgical procedure for treating severe emphysema and other lung diseases. It involves removing a portion of the over-expanded, diseased lung tissue that has lost its gas exchange function, allowing the remaining healthy lung tissue to regain its elasticity and thus improving the patient's respiratory function. In this field, bronchoscopic implantation of a one-way ventilation valve has emerged as a minimally invasive lung volume reduction approach. Once implanted in the target bronchus, this valve allows distal secretions and air to escape but prevents inhalation, thereby inducing the target lung lobe to slowly collapse, achieving a volume reduction effect of "non-physical lung tissue removal." Currently, bronchial one-way valves appearing in clinical practice and research can be mainly classified into the following types based on their design principles and fixation methods: First, the anchored valve, which has anchoring legs or barbs around its valve body, achieving initial fixation by embedding into the bronchial mucosa; second, the membrane-covered self-expanding stent valve, which combines a one-way valve with a self-expanding metal stent, relying on the stent's continuous radial support to fit tightly against the bronchial wall; and third, the highly adaptable umbrella-shaped or plug-shaped valve, which uses a shape-memory frame (such as nickel-titanium alloy) covered with a membrane material, opening like an umbrella upon release, utilizing its large contact area and flexibility to adapt to bronchimeters of different diameters. Despite their diverse forms, the core design of these existing technologies focuses on how to achieve stable implantation and one-way ventilation within a single bronchial segment.

[0003] The aforementioned types of unidirectional valves exhibit significant common defects in clinical applications, particularly in addressing the common and severe physiological response of postoperative coughing. The primary and fundamental problem lies in the severe inadequacy of fixation reliability. Existing valves rely on static fixation mechanisms such as radial support, anchoring, or umbrella-like adhesion, which are highly susceptible to failure when subjected to the strong axial impact force generated by coughing, leading to valve displacement or even detachment. This not only directly causes treatment failure but also carries the potential risk of airway obstruction and suffocation caused by coughed-up material. Without resolving this fundamental problem, other functional designs of the valve (such as sputum clearance) become meaningless.

[0004] To address the aforementioned issues, the applicant took a different approach, departing from the traditional design philosophy of solving all problems within a single lumen. Instead, they innovatively proposed utilizing the anatomical structure of bronchial bifurcation to achieve dynamic self-locking. Based on this, they designed a self-locking bronchial one-way ventilation valve that becomes increasingly stable with each cough and also possesses highly efficient sputum expectoration capabilities. Summary of the Invention

[0005] The purpose of this invention is to provide a self-locking bronchial one-way ventilation valve. This valve, through ingenious mechanical design, transforms the axial impact force generated during coughing into a stronger, more secure self-locking force, achieving "dynamic self-locking" and effectively preventing valve displacement and dislodgement. It significantly improves functional sputum expectoration. While maintaining unidirectional ventilation, it incorporates a dedicated sputum expectoration structure that can be instantaneously opened using cough pressure, ensuring effective sputum drainage and avoiding the risk of distal blockage and infection.

[0006] The present invention is implemented as follows: it includes a flexible connector, which includes at least two connecting ends, wherein the two connecting ends are respectively provided with a self-locking mechanism and a one-way ventilation mechanism; when the self-locking mechanism is subjected to axial impact force of the bronchus, the tightness of the fit between its side wall and the inner wall of the bronchus increases; the one-way ventilation mechanism allows gas to pass through in one direction, and its edge area can be temporarily opened when subjected to axial impact force during coughing to expel sputum.

[0007] Furthermore, the self-locking mechanism includes a pressure receiving ring, multiple telescopic rods, multiple arc-shaped anchor plates, and a transmission unit; one end of each telescopic rod is simultaneously connected to the end of a flexible connector, and the other end of each telescopic rod is fixedly connected to multiple anchor plates respectively; a spring is fitted between the telescopic rod and the flexible connector; the pressure receiving ring is located at the far end of the entire self-locking mechanism, and the transmission unit is connected to both the pressure receiving ring and the telescopic rods; the axial impact force received by the pressure receiving ring is transmitted to the anchor plates through the transmission unit, increasing the pressure of the anchor plates on the bronchus wall.

[0008] Furthermore, the transmission unit includes a limiting rod and a wedge block. One end of the limiting rod is connected to the pressure receiving ring, and the other end is slidably connected to the inclined surface of the wedge block.

[0009] Furthermore, the transmission unit includes a guide rod, multiple transmission rods, and a slider; the end of the guide rod is fixedly connected to a flexible connector, the slider is slidably sleeved on the guide rod, and the pressure receiving ring is connected to the slider; one end of each of the multiple transmission rods is rotatably connected to the slider, and the other end is rotatably connected to the corresponding telescopic rod.

[0010] Furthermore, the flexible connector includes a connecting block and at least two flexible supports; one end of the support is rotatably connected to the connecting block; the other end is connected to a self-locking mechanism or a one-way ventilation mechanism.

[0011] Furthermore, the one-way ventilation mechanism includes a ring frame, a one-way valve, and a sputum clearance unit; the proximal end of the ring frame is connected to a flexible connector, and the one-way valve is installed in the central channel of the ring frame; a sputum clearance channel is provided in the side wall of the ring frame, and the sputum clearance unit is located in the sputum clearance channel; the sputum clearance unit will automatically open the sputum clearance channel when subjected to axial impact force.

[0012] Furthermore, the sputum clearance unit includes a ring-shaped miniature airbag and a connecting switch. The miniature airbag is attached to the outer wall of the ring frame, and the connecting switch is slidably disposed on the side wall of the ring frame. The connecting switch has a through hole corresponding to the size of the sputum clearance channel. One end of the connecting switch is connected to the miniature airbag, and the other end is located in the central channel of the ring frame.

[0013] Furthermore, the one-way valve is either a duckbill valve or a one-way valve.

[0014] Furthermore, the sputum clearance unit includes a one-way valve and a sliding ring. The sliding ring is slidably disposed at the far end of the annular frame, and a sputum clearance channel is also opened on the sliding ring. The top of the sliding ring is an annular protrusion structure and is inserted into the sputum clearance channel of the annular frame. The one-way valve is an annular structure and is disposed in the sputum clearance channel. The sliding ring connects the two sputum clearance channels by opening the one-way valve.

[0015] Furthermore, the one-way valve is an umbrella-shaped valve.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] 1. The ventilation valve of this application, through its innovative self-locking structure design, dynamically transforms the axial impact force generated by physiological activities such as coughing, which is prone to valve displacement, into a radial pressure force that enhances fixation, achieving active fixation that is "more stable the more you cough," fundamentally overcoming the defect of traditional valves that are not securely fixed. At the same time, the sputum drainage structure set on the unidirectional ventilation mechanism can open instantly under the high pressure of coughing, ensuring effective sputum drainage. This successfully breaks through the technical bottleneck of traditional valves that hinder secretion drainage due to their single function, thus significantly improving the safety, stability, and functionality of the valve in dynamic physiological environments.

[0018] 2. A connecting switch is installed through the side wall of the annular frame, with a through hole inside that has the same diameter as the sputum drainage channel of the annular frame. The end of the connecting switch away from the micro-inflator extends into the central channel of the annular frame. This structure allows the one-way valve to open only slightly during normal breathing to maintain normal exhalation while the sputum drainage channel remains closed. When coughing, the opening of the one-way valve increases significantly, and its outward force directly drives the connecting switch to open the sputum drainage channel to facilitate sputum discharge. At the same time, the connecting switch is connected to the micro-inflator. When the one-way valve opens, it compresses the micro-inflator, increasing its internal pressure and thus enhancing the radial pressure of the entire sputum drainage unit on the bronchial wall, forming an auxiliary fixation on top of the self-locking mechanism. In addition, the micro-inflator is fixedly sleeved on the outer wall of the annular frame, and its soft material properties allow it to adapt to bronchial tubes of different diameters and achieve stable anchoring.

[0019] 3. A spring is fitted between the telescopic rod and the flexible connector. Under the pre-tension of the spring, the anchor plate is driven to expand radially, allowing it to adaptively conform to the inner wall of the bronchus with different diameters without causing excessive pressure on the wall, thus achieving initial stable anchoring. When subjected to a strong axial impact force caused by coughing, this impact force is converted into an additional radial pressure force on the anchor plate through the combined action of the pressure receiving ring and the transmission unit. This dynamic pressure works in conjunction with the initial spring force to further enhance the squeezing force on the bronchial wall at the moment of coughing, significantly improving the overall fixation effect of the valve.

[0020] 4. In the flexible connector, the flexible stent end is rotatably disposed within the connecting block. This structure allows the horizontal angle between the two stents to be adaptively adjusted according to the actual horizontal anatomical angle at the bronchial bifurcation, thereby facilitating the operator to accurately place each stent into the corresponding branch bronchus. In addition, the number of stents can be set to multiple according to clinical needs to adapt to bronchial anatomy structures with three or more branches. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the use of a self-locking bronchial one-way ventilation valve provided in Embodiment 1 of the present invention;

[0022] Figure 2 This is a schematic diagram of the installation of a self-locking bronchial one-way ventilation valve at the bronchial bifurcation provided in Embodiment 1 of the present invention;

[0023] Figure 3 This is a schematic diagram of the self-locking mechanism provided in Embodiment 1 of the present invention;

[0024] Figure 4 This is a schematic diagram of the one-way ventilation mechanism provided in Embodiment 1 of the present invention;

[0025] Figure 5 This is a schematic diagram of the overall structure of the flexible connector with three connection ends provided in Embodiment 1 of the present invention;

[0026] Figure 6 yes Figure 5 Enlarged view of point A in the middle;

[0027] Figure 7 This is a schematic diagram of the installation of a self-locking bronchial one-way ventilation valve at the bronchial bifurcation point, as provided in Embodiment 2 of the present invention.

[0028] Figure 8 This is a schematic diagram of the self-locking mechanism provided in Embodiment 2 of the present invention;

[0029] Figure 9This is a schematic diagram of the installation of a self-locking bronchial one-way ventilation valve at the bronchial bifurcation provided in Embodiment 3 of the present invention;

[0030] Figure 10 This is a schematic diagram of the one-way ventilation mechanism provided in Embodiment 3 of the present invention;

[0031] Figure 11 This is a schematic diagram of the installation of another type of ventilation valve at the bronchial bifurcation provided in Embodiment 3 of the present invention;

[0032] Figure 12 This is a schematic diagram of another form of one-way ventilation mechanism provided in Embodiment 3 of the present invention;

[0033] Figure 13 This is a schematic diagram of the installation of a self-locking bronchial one-way ventilation valve at the bronchial bifurcation provided in Embodiment 4 of the present invention.

[0034] Figure 14 This is a schematic diagram of the one-way ventilation mechanism provided in Embodiment 4 of the present invention.

[0035] Reference numerals used in the above figures:

[0036] 1. Bronchi; 2. Stent; 3. Anchor plate; 4. Pressure receiving ring; 5. Sputum drainage channel; 6. Conical valve; 7. Circular frame; 8. Connecting block; 9. Telescopic rod; 10. Wedge block; 11. Sliding ring; 12. Limiting rod; 13. Spring; 14. Miniature airbag; 15. Connecting switch; 16. Transmission rod; 17. Slider; 18. Guide rod; 19. Duckbill valve; 20. Circular groove; 21. One-way valve; 22. Umbrella valve; 23. One-way valve disc; 24. Top valve ring. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0038] The implementation of the present invention will be described in detail below with reference to specific embodiments.

[0039] In the accompanying drawings of this embodiment, the same or similar reference numerals correspond to the same or similar components. In the description of this invention, it should be understood that if terms such as "upper," "lower," "left," and "right" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, they are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the accompanying drawings are only for illustrative purposes and should not be construed as limiting this patent. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0040] Reference Figures 1-12 The image shown is a preferred embodiment of the present invention.

[0041] Example 1: A self-locking bronchial one-way ventilation valve, mainly composed of three parts: a flexible connector, a self-locking mechanism, and a one-way ventilation mechanism. The flexible connector consists of a connecting block 8 and multiple flexible supports 2, the number of which can be adapted according to the number of branches of the target bronchus 1. Figure 2 As shown, in one application scenario of this embodiment, two flexible stents 2 are used. In use, the two stents 2 can be placed into two bifurcated bronchi 1 respectively: the end of one stent 2 is connected to a self-locking mechanism to anchor to the healthy bronchus 1 segment and provide the main fixation force; the end of the other stent 2 is connected to a one-way ventilation mechanism to be implanted into the diseased bronchus 1 segment that requires lung volume reduction to achieve one-way ventilation function.

[0042] To accommodate the anatomical differences in the bifurcation angle of bronchus 1 among different patients, this embodiment provides an annular groove 20 on the side wall of the connecting block 8. For example... Figure 6 As shown, each support 2 has a protrusion at its end, which is slidably inserted into the annular groove 20. The connection structure has a certain damping, which allows the support 2 to adjust its horizontal angle when under force and maintain a stable position after adjustment, thereby ensuring that the valve can accurately match the specific bifurcation shape of the bronchus 1.

[0043] Furthermore, the flexible connector can be extended to a structure with three or more supports 2 to accommodate more complex bronchial bifurcation 1 (e.g., a three-way bifurcation), such as... Figure 5 As shown. In this extended configuration, the number of self-locking mechanisms and unidirectional ventilation mechanisms can be configured according to clinical needs: for example, configuring two self-locking mechanisms can significantly enhance the overall fixation effect; while configuring two unidirectional ventilation mechanisms is suitable for treatment scenarios where multiple bronchi 1 require lung volume reduction. Those skilled in the art will understand that as long as the number of stents 2 is two or more, it falls within the protection scope of this application.

[0044] The self-locking mechanism structure in this embodiment is as follows: Figure 3As shown, it mainly consists of a pressure receiving ring 4, a telescopic rod 9, an arc-shaped anchoring plate 3, and a transmission unit. To minimize the impact on the patient's breathing resistance, this embodiment preferably sets the number of both the telescopic rod 9 and the arc-shaped anchoring plate 3 to two.

[0045] Two telescopic rods 9 are symmetrically fixed to both sides of the end of the support 2. Two arc-shaped anchoring plates 3 have their concave surfaces fixedly connected to the telescopic sections of the corresponding telescopic rods 9. To achieve adaptive anchoring of the self-locking mechanism in bronchial tubes 1 of different diameters, a spring 13 is sleeved on the telescopic rod 9. One end of the spring 13 is fixed to the telescopic section of the telescopic rod 9, and the other end is fixed to the side wall of the end of the support 2. When the self-locking mechanism is placed in a healthy bronchial tube 1 section, the arc-shaped anchoring plate 3, under the preload of the spring 13, can maintain a tight fit with the inner wall of the bronchial tube 1, forming an initial stable anchoring.

[0046] The transmission unit is the core of achieving dynamic self-locking, and mainly consists of a wedge block 10 and a limiting rod 12. For example... Figure 3 As shown, the cross-section of the wedge block 10 is approximately a right-angled triangle. The horizontal right-angled side of the wedge block 10 is fixedly connected to the telescopic section of the telescopic rod 9, and the vertical right-angled side of the wedge block 10 is fixedly connected to the concave surface of the arc-shaped anchor plate 3. A groove (not marked in the figure) is provided on the inclined surface of the wedge block 10. The protrusion at the top of the limiting rod 12 is slidably inserted into this groove, and the bottom of the limiting rod 12 is fixedly connected to the pressure receiving ring 4.

[0047] Its self-locking working principle is as follows: When the pressure receiving ring 4 is subjected to axial impact force generated by coughing, it will drive the limiting rod 12 to move. The protrusion at the top of the limiting rod 12 will then slide in the inclined groove of the wedge block 10, thereby squeezing the wedge block 10. This squeezing action forces the two telescopic rods 9 to move radially outward, thereby pushing the two arc-shaped anchoring plates 3 to press more tightly against the bronchus 1 wall. This mechanism transforms the harmful axial impact force into a radially pressing force that enhances fixation, achieving the self-locking effect of "the greater the impact force, the more stable the fixation".

[0048] The one-way ventilation mechanism structure in this embodiment is as follows: Figure 4 As shown, it mainly consists of a ring frame 7, a one-way valve, and multiple sets of sputum drainage units. A central channel is provided in the middle of the ring frame 7, and the one-way valve is installed within this central channel. In this embodiment, the one-way valve is composed of multiple arc-shaped conical valves 6 (also called "leaflets"). The arc-shaped edges of each conical valve 6 are hinged to the inner wall of the central channel. The conical valves 6 are made of rigid material. In their natural state, the valves are constrained by the hinged structure and close together to form a conical sealing surface, constituting a one-way sealing structure.

[0049] To further optimize sputum drainage, multiple sputum drainage channels 5 are circumferentially formed on the side wall of the annular frame 7. To facilitate the drainage of sputum accumulated between the surface of the annular frame 7 and the wall of the bronchus 1, the inlet end of each drainage channel 5 is designed as a funnel-shaped structure for effective drainage. When the patient coughs, sputum located at the edge of the annular frame 7 can enter the drainage channel 5 through this funnel-shaped opening.

[0050] In this embodiment, four sputum drainage channels 5 are arranged evenly around the central channel. The number of sputum drainage units is the same as the number of sputum drainage channels 5, used to control the opening and closing of the corresponding sputum drainage channels 5. Specifically, four through slots are correspondingly opened on the side wall of the annular frame 7, and the miniature airbags 14 are fixedly installed in the through slots. A connecting switch 15 (which can be regarded as a slide valve) is slidably disposed in the through slot, one end of which is fixedly connected to the miniature airbag 14, and the other end extends into the interior of the central channel. The connecting switch 15 has a through hole. When it is pushed and slids to the maximum stroke position, the through hole will connect with the sputum drainage channel 5 on the annular frame 7, thereby realizing the connection of the sputum drainage channel 5 and allowing sputum to be discharged through it.

[0051] The working principle of the one-way ventilation mechanism is as follows: When the patient breathes normally, the exhaled airflow pressure is low, only enough to slightly open the cone valve 6. At this time, the displacement of the valve is insufficient to push the connecting switch 15 to its maximum position, and the sputum clearance channel 5 remains closed. When the patient coughs, the resulting intense axial impact force causes the cone valve 6 to open significantly, enough to push the connecting switch 15 to its maximum position. During this process, the connecting switch 15 compresses the micro-inflator 14, increasing its internal pressure, while the through-hole on it aligns and connects the sputum clearance channel 5. At this time, a large amount of sputum is mainly discharged from the central channel through the opened cone valve 6; while the marginal sputum attached to the junction of the annular frame 7 and the bronchial wall 1 is effectively discharged through the connected sputum clearance channel 5. In addition, when the micro-inflator 14 is compressed and the pressure increases, its overall expansion increases, thereby enhancing the radial compression force on the bronchial wall 1, achieving the effect of assisting in enhancing the overall valve stability during coughing.

[0052] Example 2: A self-locking bronchial one-way ventilation valve, whose overall composition is basically the same as that of Example 1, the main difference being the specific structure of the transmission unit in the self-locking mechanism. For example... Figure 7 and Figure 8 As shown, the transmission unit in this embodiment mainly consists of two transmission rods 16, a guide rod 18, and a slider 17. One end of the guide rod 18 is fixedly connected to the end of the bracket 2, and the slider 17 is slidably sleeved on the guide rod 18. One end of each of the two transmission rods 16 is rotatably connected to the slider 17, and the other end is rotatably connected to the side wall of the telescopic section of the corresponding telescopic rod 9.

[0053] When the slider 17 slides along the guide rod 18 toward the bracket 2 under the action of force, the two transmission rods 16 are linked together to push the two telescopic rods 9 and their connected anchoring plates 3 to unfold outward, thereby enhancing the radial pressure on the wall of the bronchus 1 and achieving a more secure anchoring.

[0054] The pressure receiving ring 4 is connected to the slider 17 via a support frame in its middle. When the pressure receiving ring 4 is subjected to an impact force along the axial direction of the bronchus 1, the impact force is transmitted to the slider 17 via the support frame, causing the slider 17 to move along the guide rod 18. The axial impact force is then converted into a radial pressure force that extends outward from the anchor plate 3 through the aforementioned transmission mechanism, forming a dynamically enhanced fixing effect.

[0055] Other structures not detailed in this embodiment are the same as in Embodiment 1 and will not be described again here.

[0056] It should be noted that any self-locking mechanism structure that can convert the axial impact force of the bronchus 1 into a radially expanding compressive force on the wall of the bronchus 1, regardless of its specific implementation, shall be considered to fall within the protection scope of the claims of this application.

[0057] Example 3: A self-locking bronchial one-way ventilation valve, whose overall composition is basically the same as that of Example 1, the main difference being the specific structural form of the one-way valve.

[0058] like Figure 9 and Figure 10 As shown, in this embodiment, the one-way valve is a duckbill valve 19. During normal breathing, the exhaled airflow acts on the duckbill valve 19 to open it, achieving one-way ventilation; when the patient coughs, the strong axial impact force generated causes the opening of the duckbill valve 19 to increase significantly, and pushes the connecting switch 15 to move, thereby squeezing the micro airbag 14.

[0059] To further enhance adaptability, in this embodiment, the micro-airbag 14 is directly fitted onto the outer wall of the annular frame 7. The annular micro-airbag 14 is made of flexible material and can adapt to the inner wall of the bronchus 1 with different diameters, ensuring effective fit and stable support under different anatomical structures.

[0060] To optimize the sputum drainage pathway, this embodiment also includes an annular protrusion structure on the side wall of the annular frame 7 corresponding to the funnel opening. This design helps guide the sputum accumulated between the annular frame 7 and the inner wall of the bronchus 1 to enter the funnel opening more smoothly and be discharged through the sputum drainage channel 5.

[0061] One-way valves can also be used as follows Figure 11 and Figure 12The one-way valve 21 structure is shown. When subjected to axial impact forces such as coughing, the valve body of the one-way valve 21 expands outward, thereby pushing the connecting switch 15 to move and ultimately realizing the opening and control of the sputum drainage channel 5.

[0062] It should be noted that the conical valve 6, duckbill valve 19, and one-way valve 21 described above are merely examples of structures capable of realizing the functions of this application. Any one-way valve structure, regardless of its form, that can generate outward expansion under the action of airflow and thereby drive the connecting switch 15 to achieve the corresponding function, falls within the protection scope of the claims of this application.

[0063] Example 4: A self-locking bronchial one-way ventilation valve, whose overall composition is basically the same as that of Example 1, the main difference being the specific structural form of the one-way valve and the structure of the sputum expectoration unit.

[0064] like Figure 13 and Figure 14 As shown, in this embodiment, the one-way valve adopts an umbrella-shaped valve 22. The sputum drainage unit mainly consists of a sliding ring 11 and an annular one-way valve 23. The sputum drainage channel 5 has an annular structure, and the sliding ring 11 is slidably disposed at the end of the annular frame 7. The top of the sliding ring 11 is provided with an annular protrusion structure (hereinafter referred to as "top valve ring 24"), and the top valve ring 24 is inserted into the annular sputum drainage channel 5. The fixed end of the umbrella-shaped valve 22 is installed at the distal end of the top valve ring 24. The sliding ring 11 and the top valve ring 24 are respectively provided with corresponding and communicating annular sputum drainage channels 5.

[0065] The working principle of the sputum clearance unit in this embodiment is as follows: When the patient breathes normally, the exhaled airflow causes the umbrella-shaped valve 22 to contract, and the airflow is discharged through the annular gap formed between the umbrella-shaped valve 22 and the inner wall of the annular frame 7. At this time, the sputum clearance channel 5 is in a closed state. When the patient coughs, the strong axial impact force generated pushes the sliding ring 11 and the top valve ring 24 to slide into the sputum clearance channel 5, thereby pushing open the annular one-way valve 23, opening the annular sputum clearance channel 5, and realizing the discharge of sputum.

[0066] The valve implantation procedures in Examples 1-4 were all performed using guidewire guidance. Specifically, during the procedure, guidewires, corresponding in number to the number of stents 2, were pre-placed into each branch of the target bronchus 1. Subsequently, the ends of each stent 2 were aligned with the proximal ends of the guidewires using flexible connectors, allowing the entire valve's self-locking mechanism and one-way ventilation mechanism to be fitted onto the guidewires, which were then pushed along the guidewires to the predetermined positions at the bifurcation of bronchus 1. This guidewire guidance mechanism ensured that each stent 2 was accurately and synchronously introduced into the corresponding branch of bronchus 1, thereby completing the overall valve implantation.

[0067] It should be noted that any sputum clearance unit structure that can keep the sputum clearance channel 5 closed during normal breathing and open the sputum clearance channel 5 when subjected to a strong axial impact force, regardless of its specific implementation, falls within the protection scope of this application.

[0068] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A self-locking bronchial one-way ventilation flap, characterized in that The flexible connecting piece comprises at least two connecting ends, each of which is provided with a self-locking mechanism and a one-way ventilation mechanism; when the self-locking mechanism is subjected to an axial impact force of the bronchus (1), the tightness between the side wall of the self-locking mechanism and the inner wall of the bronchus (1) increases; the one-way ventilation mechanism allows gas to pass in one direction, and the edge area thereof can be temporarily opened to discharge sputum when subjected to an axial impact force during coughing. The self-locking mechanism comprises a pressure receiving ring (4), a plurality of telescopic rods (9), a plurality of arc-shaped anchor plates (3) and a transmission unit; one end of each of the plurality of telescopic rods (9) is connected to the end of the flexible connecting piece, and the other end of each of the plurality of telescopic rods (9) is fixedly connected to a corresponding one of the plurality of anchor plates (3); a spring (13) is sleeved between each of the plurality of telescopic rods (9) and the flexible connecting piece; the pressure receiving ring (4) is located at the distal end of the entire self-locking mechanism, and the transmission unit is connected to the pressure receiving ring (4) and the plurality of telescopic rods (9); the transmission unit transmits the axial impact force received by the pressure receiving ring (4) to the anchor plates (3), thereby increasing the pressure of the anchor plates (3) on the wall of the bronchus (1).

2. A self-locking bronchial one-way valve according to claim 1, characterized in that The transmission unit comprises a limiting rod (12) and a wedge-shaped block (10); one end of the limiting rod (12) is connected to the pressure receiving ring (4), and the other end of the limiting rod (12) is slidingly connected to the inclined surface of the wedge-shaped block (10).

3. The self-locking bronchial one-way valve according to claim 1, wherein, The transmission unit comprises a guide rod (18), a plurality of transmission rods (16) and a sliding block (17); the end of the guide rod (18) is fixedly connected to the flexible connecting piece, the sliding block (17) is slidingly sleeved on the guide rod (18), and the pressure receiving ring (4) is connected to the sliding block (17); one end of each of the plurality of transmission rods (16) is rotatably connected to the sliding block (17), and the other end of each of the plurality of transmission rods (16) is rotatably connected to a corresponding one of the plurality of telescopic rods (9).

4. The self-locking bronchial one-way valve according to claim 1, wherein, The flexible connecting piece comprises a connecting block (8) and at least two flexible supports (2); one end of each of the at least two flexible supports (2) is movably connected to the connecting block (8); the other end of each of the at least two flexible supports (2) is connected to the self-locking mechanism or the one-way ventilation mechanism.

5. The self-locking bronchial one-way valve according to any one of claims 1-4, characterized in that, The one-way ventilation mechanism comprises a ring-shaped frame (7), a one-way valve and a sputum discharge unit; the proximal end of the ring-shaped frame (7) is connected to the flexible connecting piece, the one-way valve is installed in the central passage of the ring-shaped frame (7); a sputum discharge passage (5) is arranged in the side wall of the ring-shaped frame (7), and the sputum discharge unit is arranged in the sputum discharge passage (5); the sputum discharge unit is automatically opened to open the sputum discharge passage (5) when subjected to an axial impact force.

6. A self-locking bronchial one-way valve according to claim 5, characterized in that The sputum discharge unit comprises a ring-shaped micro air bag (14) and a communication switch (15); the ring-shaped micro air bag (14) is attached to the outer side wall of the ring-shaped frame (7), and the communication switch (15) is slidingly and penetratingly arranged on the side wall of the ring-shaped frame (7); a through hole corresponding in size to the sputum discharge passage (5) is formed in the communication switch (15); one end of the communication switch (15) is connected to the micro air bag (14), and the other end of the communication switch (15) is located in the central passage of the ring-shaped frame (7).

7. A self-locking bronchial one-way valve according to claim 6, characterized in that The one-way valve is a duckbill valve (19) or a one-way valve (21).

8. A self-locking bronchial one-way valve according to claim 7, characterized in that The sputum discharge unit comprises a one-way valve (23) and a sliding ring (11), the sliding ring (11) is slidingly arranged at the distal end of the annular frame (7), the sliding ring (11) is also provided with a sputum discharge channel (5), the top of the sliding ring (11) is annularly protruded and is inserted into the sputum discharge channel (5) of the annular frame (7); the one-way valve (23) is annularly arranged in the sputum discharge channel (5); the sliding ring (11) opens the one-way valve (23) to realize the communication of the two sputum discharge channels (5).

9. A self-locking bronchial one-way valve according to claim 8, characterized in that The one-way valve is an umbrella-shaped valve (22).

Images