One-way valve device

Abstract

The invention discloses a one-way valve device which comprises a one-way valve assembly and a fixing assembly. The one-way valve assembly comprises a protection support and a one-way valve. The fixing assembly comprises a fixing film and a fixing sealing ring. According to the invention, a proper fixed sealing ring type can be selected according to the actual measured length of a bronchus section, which needs to be implanted, of an emphysema patient to adapt to patients with different bronchus section lengths, so that the patients can obtain bronchus one-way valve treatment, the mounting and dismounting modes are simple and rapid, and meanwhile, the stability can be ensured; the fixed sealing ring with proper size, shape and line width can be selected according to the actually measured diameter of a bronchus section needing to be implanted into an emphysema patient, so that the fixed sealing ring has more proper radial force, and the phenomena that granulation hyperplasia of a bronchus wall is caused by too large radial force or the one-way valve falls off or coughs out due to too small radial force, and the function of the one-way valve fails are avoided; pains and economic burdens of patients are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a one-way valve device. Background Art

[0002] Chronic obstructive pulmonary disease is characterized by high morbidity and mortality, and is mainly manifested by irreversible chronic airway obstruction and lung hyperinflation, with pathological lung parenchyma manifested as emphysema. Currently, the method of transbronchial lung volume reduction is widely studied, in which a one-way valve is placed in the target area. Its working principle is to use a one-way valve to prevent outside air from entering the emphysema area, while allowing residual gas or secretions in the emphysema area to be discharged through the one-way valve, that is, the one-way valve is used to limit the ventilation of the lung tissue in the emphysema area, causing the lung tissue in the emphysema area to collapse, thereby achieving the effect of alleviating lung disease.

[0003] However, the one-way bronchial valve currently used in clinical practice often fails to meet the implantation requirements because its supporting and fixing length is greater than the length of the bronchial segment where the patient is implanted, making it impossible for such emphysema patients to receive bronchial one-way valve treatment. In addition, when the patient coughs violently, the one-way valve implanted in the bronchus will fall off or be coughed out due to insufficient radial support, causing it to lose its therapeutic effect and require re-implantation, which undoubtedly increases the patient's surgical pain and economic burden. Summary of the invention

[0004] In order to solve the above technical problems, the present invention provides a one-way valve device.

[0005] In order to have a basic understanding of some aspects of the disclosed embodiments, a brief summary is given below. This summary is not intended to be a general review, nor is it intended to identify key / important components or to delineate the scope of protection of these embodiments. Its only purpose is to present some concepts in a simple form as a preface to the detailed description that follows.

[0006] The present invention adopts the following technical solution:

[0007] The present invention provides a one-way flap device, comprising: a one-way flap assembly and a fixing assembly;

[0008] The one-way flap assembly comprises: a protection bracket and a one-way flap located in the protection bracket, a coating is provided on the surface of the protection bracket and the coating is connected to the one-way flap;

[0009] The fixing assembly includes: a fixing film and a fixing sealing ring, one side of the fixing film is connected to the covering film at the distal end of the protection bracket, and the other side extends toward the direction of the proximal end of the protection bracket to form an annular portion surrounding the distal end of the protection bracket;

[0010] The inner surface of the annular portion is provided with two rows of T-shaped protrusions which are arranged circumferentially, staggered and evenly spaced. The fixed sealing ring is provided with two groups of clamping positions, which are respectively clamped on the two rows of T-shaped protrusions to press the annular portion against the inner wall of the bronchus.

[0011] Wherein, the fixed sealing ring is a wavy ring structure, and each wave crest of the wavy ring structure constitutes one group of the clamping positions, and each wave trough constitutes another group of the clamping positions, and they are respectively clamped on the two rows of T-shaped protrusions.

[0012] Among them, the number of wave crests of the wavy ring structure is the same as the number of wave troughs, and is consistent with the number of T-shaped protrusions in a single row; the number of wave crests of the wavy ring structure is 3 to 12, and the line width of the wavy ring structure is 0.1 to 0.3 mm.

[0013] Among them, the fixed sealing ring is a grid-like ring structure composed of diamond frames connected in sequence, and the corners on one side of each diamond frame constitute one group of the clamping positions, and the corners at the joints of each diamond frame constitute another group of the clamping positions, and are respectively clamped on the two rows of T-shaped protrusions.

[0014] Among them, the number of grids formed by the diamond frames in the fixed sealing ring is consistent with the number of the T-shaped protrusions in a single row; the number of grids formed by the diamond frames in the fixed sealing ring is 3 to 12, and the line width of the grid-like ring structure is 0.1 to 0.3 mm.

[0015] Among them, the fixed sealing ring includes a wavy ring structure and a grid-like ring structure composed of diamond frames connected in sequence; the wave peaks of the wavy ring structure constitute one group of the clamping positions, and the bottom side corner intervals of the grid-like ring structure select a corner to form another group of the clamping positions, and are respectively clamped on the two rows of T-shaped protrusions.

[0016] Among them, the number of wave peaks of the wavy annular structure is consistent with the number of T-shaped protrusions in a single row, and the number of grids formed by the diamond frames in the grid-shaped annular structure is twice the number of T-shaped protrusions in a single row; the number of wave peaks of the wavy annular structure and the number of grids formed by the diamond frames in the grid-shaped annular structure are 3 to 12, and the line width of the wavy annular structure and the line width of the grid-shaped annular structure are 0.1 to 0.3 mm.

[0017] Wherein, the protective support is a hollow tubular structure, the one-way valve is located inside the hollow tubular structure, and the shape of the one-way valve includes but is not limited to a duckbill shape, a cross shape or a wave shape.

[0018] Wherein, a pull ring is arranged on the fixed sealing ring, the pull ring is inclined toward the axis side of the fixed sealing ring, and the number of the pull rings is 2-4.

[0019] The fixing film is made of elastic polymer material; the protection bracket and the fixing sealing ring are elastic frames with shape memory formed by laser cutting and heat setting of nickel-titanium alloy tubes or laser welding of nickel-titanium alloy wires.

[0020] The beneficial effects brought by the present invention are:

[0021] 1. According to the actual measured length of the bronchial segment to be implanted in the emphysema patient, the appropriate fixed sealing ring type can be selected to adapt to patients with different bronchial segment lengths, so that they can all receive bronchial one-way valve treatment, and the installation and removal methods are simple and quick, while also ensuring stability;

[0022] 2. According to the actual measured diameter of the bronchial segment to be implanted in the emphysema patient, a fixed sealing ring of appropriate size, shape and line width can be selected to make the fixed sealing ring have a more appropriate radial force, to avoid excessive radial force causing bronchial wall granulation hyperplasia or too small radial force causing the one-way valve to fall off or cough up, making the one-way valve function ineffective, and reducing the patient's pain and economic burden;

[0023] 3. The fixed sealing ring contains a pull ring, which allows you to use a grasping forceps to hold the one-way valve more firmly and remove it. It is not easy to fall off during the removal process, which reduces the difficulty of removal and reduces the pain of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 is a schematic diagram of a one-way flap device of the present invention without a fixed sealing ring installed;

[0026] Figure 2 It is a schematic plan view of the present invention after the T-shaped protrusion clamps the wavy fixed sealing ring after it is unfolded;

[0027] Figure 3 is a top view schematic diagram of a one-way flap device with three wave peaks of the present invention;

[0028] Figure 4 It is a schematic plan view of the present invention after the T-shaped protrusion clamps the grid-shaped fixed sealing ring after it is unfolded;

[0029] Figure 5is a top view schematic diagram of a one-way flap device with six grids of the present invention;

[0030] Figure 6 It is a plan view of the present invention in which the T-shaped protrusion clamps the fixed sealing ring in the wave shape and the grid shape after it is unfolded;

[0031] Figure 7 is a top view schematic diagram of a one-way flap device having six wave crests and twelve grids according to the present invention;

[0032] Figure 8 is a schematic diagram of the one-way flap device of the present invention when it is implanted in a bronchus;

[0033] Fig. 9 It is a schematic diagram of the grasping forceps of the present invention grasping the one-way flap device. DETAILED DESCRIPTION

[0034] The embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. It should be clear that the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] like Figure 1-9 As shown, in some illustrative embodiments, a one-way valve device is provided, comprising: a one-way valve assembly and a fixing assembly. The one-way valve assembly is used to prevent external air from entering the bronchus and to discharge residual gas and secretions; the fixing assembly is used to fix the one-way valve assembly to the inner wall of the bronchus.

[0036] The one-way flap assembly comprises: a protection bracket 1 and a one-way flap 2.

[0037] The protective stent 1 is a hollow tubular structure. The hollow design helps to reduce the weight of the stent and realize deformation and expansion and contraction and storage. The diameter of the protective stent 1 is smaller than the diameter of the trachea to be implanted, so that it can pass through the opening of the trachea smoothly during implantation and be deployed at a predetermined position. The protective stent 1 surrounds the one-way valve 2 to ensure that the one-way valve 2 can maintain its shape and function after being implanted in the trachea and is not squeezed and deformed by the pressure in the trachea or the external pressure.

[0038] The surface of the protective stent 1 is provided with a coating and the coating is connected to the one-way valve 2. The coating is usually made of a biocompatible material, which tightly covers the surface of the protective stent 1 and fits the hollow structure of the protective stent 1 without affecting the elastic expansion of the protective stent 1. The design of the coating can prevent gas from entering and exiting through the hollow structure of the protective stent 1, and can prevent bacterial infection and secretion accumulation, and reduce inflammatory response.

[0039] The one-way valve 2 is a one-way ventilation valve located in the protective stent 1, which opens when the patient exhales to allow gas and secretions to be discharged, and closes when the patient inhales to prevent external air from entering, thereby reducing the situation of lung overinflation. Figure 3 As shown, the one-way valve 2 can be a duckbill-shaped one-way valve; Figure 5 As shown, the one-way flap 2 may be a cross-shaped one-way flap; Figure 7 As shown, the one-way valve 2 can be a wave-shaped one-way valve.

[0040] The fixed component includes: a fixed membrane 3 and a fixed sealing ring 5 .

[0041] One side of the fixed membrane 3 is connected to the covering membrane at the distal end of the protection stent 1, and the other side extends toward the proximal end of the protection stent 1 to form an annular portion surrounding the distal end of the protection stent 1, where the distal end refers to the side away from the oral cavity. The fixed membrane 3 is made of elastic polymer material, such as silicone rubber, which is a widely used biocompatible material suitable for long-term implantation in the body. Good elasticity can adapt to the shape and movement of the inner wall of the bronchus while maintaining its functionality and structure.

[0042] The inner surface of the annular portion of the fixed membrane 3 is provided with two rows of T-shaped protrusions 4 for use with the fixed sealing ring 5, and the T-shaped protrusions 4 are integrally formed with the fixed membrane 3. When implanted, the fixed sealing ring 5 is locked on the inner surface of the fixed membrane 3 by the T-shaped protrusions 4 to prevent the fixed sealing ring 5 from shifting on the fixed membrane 3, thereby pressing the fixed membrane 3 against the inner wall of the bronchus. The two rows of T-shaped protrusions 4 are arranged along the circumference of the inner wall of the fixed membrane 3 and are staggered and evenly spaced. The above arrangement helps to provide uniform support and fixing force during fixation, and is easy to operate and fix. After fixation, the structure is also more stable and not easy to fall off or shift.

[0043] The fixed sealing ring 5 is locked on the inner surface of the fixed membrane 3 via the T-shaped protrusion 4, and the one-way flap assembly is supported and fixed on the inner wall of the bronchus by pressing the fixed membrane 3 and sealing the bronchial cavity. The fixed sealing ring 5 has two groups of clamping positions, which are respectively clamped on the two rows of T-shaped protrusions 4 to prevent the fixed sealing ring 5 from shifting on the fixed membrane 3, so as to press the annular portion of the fixed membrane 3 on the inner wall of the bronchus.

[0044] The fixed sealing ring 5 and the protective bracket 1 are elastic frames with shape memory, which are formed by laser cutting and heat setting of nickel-titanium alloy tubes or laser welding of nickel-titanium alloy wires. The shape memory of nickel-titanium alloy means that it can recover to a preset shape at a specific temperature after deformation, and the superelasticity of nickel-titanium alloy enables it to stretch in a large range without permanent deformation. Therefore, the fixed sealing ring 5 and the protective bracket 1 with the above two characteristics can be compressed at ambient temperature, implanted in the body through a catheter, and recover to a predetermined shape at body temperature, and are suitable for use as implants in the body.

[0045] A pull ring 6 is arranged on the fixed sealing ring 5, and the pull ring 6 is inclined toward the axis side of the fixed sealing ring 5, and the number of the pull rings 6 is 2-4. If the one-way valve device needs to be taken out, the fiber bronchoscope one-way valve grasping forceps 7 reach the insertion position of the one-way valve implantation device, open the jaws, grasp the pull ring 6 with the grasping hook, and pull out the one-way valve device, which is easy to operate.

[0046] In some illustrative embodiments, Figure 2-3 As shown, the fixed sealing ring 5 is a wavy ring structure, and the various wave peaks 501 of the wavy ring structure constitute one group of snap positions, which are snapped onto the first row of T-shaped protrusions 4 of the fixed membrane 3, and the various wave troughs 502 of the fixed sealing ring 5 constitute another group of snap positions, and are snapped onto the second row of T-shaped protrusions 4 of the fixed membrane 3, thereby achieving locking between the fixed membrane 3 and the fixed sealing ring 5, so that the fixed membrane 3 is pressed against the inner wall of the bronchus through the fixed sealing ring 5, and finally completing the implantation and fixation of the one-way valve device.

[0047] The number of wave crests in the wave-shaped annular structure of the fixed sealing ring 5 is the same as the number of wave troughs and is consistent with the number of the single-row T-shaped protrusions 4 . The number of wave crests in the wave-shaped annular structure is 3 to 12. Figure 2-3 There are two rows of T-shaped protrusions 4 shown, with three protrusions in each row. Correspondingly, the number of wave crests and the number of wave troughs of the fixed sealing ring 5 are both three.

[0048] The line width of the wavy ring structure of the fixed sealing ring 5 is 0.1-0.3 mm. The radial support force of the fixed sealing ring 5 can be adjusted by the line width to meet the requirements of the fixed support one-way valve device. Since the fixed sealing ring is a ring-shaped body formed by the end-to-end connection of the wavy line, the width of the wavy line is the line width. Figure 2-3 The line width shown is 0.3 mm.

[0049] The shape and size design of the above-mentioned wavy ring structure not only enables the fixing component to flexibly adapt to the shape of the inner wall of the bronchus and provide a stable fixing effect, but also ensures that the fixed sealing ring 5 forms a uniform pressure distribution on the inner wall of the bronchus, reducing the risk of excessive local pressure and improving the patient's comfort and the overall stability of the device.

[0050] In some illustrative embodiments, Figure 4-5As shown, the fixed sealing ring 5 is a grid-like ring structure composed of diamond frames connected in sequence, and one side corner 503 of each diamond frame constitutes one group of snap positions, which is snapped onto the first row of T-shaped protrusions 4 of the fixed membrane 3, and the joint corners 504 of each diamond frame constitute another group of snap positions, and are snapped onto the second row of T-shaped protrusions 4 of the fixed membrane 3, thereby achieving locking between the fixed membrane 3 and the fixed sealing ring 5, so that the fixed membrane 3 is pressed against the inner wall of the bronchus through the fixed sealing ring 5, and finally completing the implantation and fixation of the one-way valve device.

[0051] The number of grids 505 formed by diamond frames in the fixed sealing ring 5 is consistent with the number of the single-row T-shaped protrusions 4 , and the number of grids 505 formed by diamond frames in the fixed sealing ring 5 is 3 to 12. Figure 4-5 There are two rows of T-shaped protrusions 4 shown, with six protrusions in each row. Correspondingly, the number of grids 505 formed by diamond frames in the fixed sealing ring 5 is six.

[0052] The line width of the grid-like annular structure is 0.1-0.3 mm, and the radial support force of the fixed sealing ring 5 can be adjusted by the line width to meet the requirements of the fixed support one-way flap device. Since the fixed sealing ring 5 is composed of diamond frames connected in sequence, the frame width of the diamond frame is the line width of the grid-like annular structure. Figure 4-5 The line width shown is 0.2 mm.

[0053] The shape and size design of the above-mentioned grid-like ring structure not only enables the fixing component to flexibly adapt to the shape of the inner wall of the bronchus and provide a more stable fixing effect, but also ensures that the fixed sealing ring 5 forms a uniform pressure distribution on the inner wall of the bronchus, reducing the risk of excessive local pressure and improving the patient's comfort and the overall stability of the device.

[0054] In some illustrative embodiments, Figure 6-7 As shown, the fixed sealing ring 5 includes a wavy annular structure and a grid-like annular structure composed of diamond-shaped frames connected in sequence. Each wave crest 501 of the wavy annular structure constitutes one group of snap-in positions, and this group of snap-in positions is snapped on the first row of T-shaped protrusions 4 of the fixed membrane 3. The top corner interval of the grid-like annular structure selects a corner to connect with each trough 502 of the wavy annular structure, and the bottom corner interval of the grid-like annular structure selects a corner to form another group of snap-in positions, and is snapped on the second row of T-shaped protrusions 4 of the fixed membrane 3. Then, the locking between the fixed membrane 3 and the fixed sealing ring 5 is realized, so that the fixed membrane 3 is pressed against the inner wall of the bronchus by the fixed sealing ring 5, and finally the implantation and fixation of the one-way valve device is completed.

[0055] The number of wave peaks of the wavy annular structure is consistent with the number of single-row T-shaped protrusions 4, and the number of grids 505 formed by diamond frames in the grid-shaped annular structure is twice the number of single-row T-shaped protrusions 4; the number of wave peaks of the wavy annular structure and the number of grids 505 formed by diamond frames in the grid-shaped annular structure are 3 to 12. Figure 6-7 There are two rows of T-shaped protrusions 4 shown, with 6 protrusions in each row. Correspondingly, the number of wave crests in the wavy ring structure is 6, and the number of grids 505 formed by diamond frames in the fixed sealing ring 5 is 12.

[0056] The line width of the wavy ring structure and the line width of the grid-like ring structure are 0.1 to 0.3 mm. Since the fixed sealing ring is a ring-shaped body formed by connecting the wavy lines end to end, the width of the wavy line is the line width, and since the fixed sealing ring 5 is composed of diamond frames connected in sequence, the frame width of the diamond frame is the line width of the grid-like ring structure. Figure 6-7 The line width shown is 0.1 mm.

[0057] like Figure 8-9 As shown, the method of using the one-way flap device of the present invention is as follows:

[0058] First, the delivery catheter reaches the target bronchial segment to be implanted through the fiber bronchoscope, and the diameter and length of the bronchial segment are measured with the delivery catheter. Since the larger the bronchial diameter, the smaller the degree of compression and deformation of the fixed sealing ring 5 is required, and the smaller the radial compression force is generated, when the diameter of the bronchial segment is larger, a fixed sealing ring with a wider line width is selected, and when the diameter of the bronchial segment is smaller, a fixed sealing ring with a narrower line width is selected. At the same time, in order to prevent the problem of displacement of the one-way valve device due to small radial compression force, it is necessary to appropriately increase the radial compression force by adjusting the parameters of the fixed sealing ring 5, and in order to prevent the problem of granulomas around the one-way valve device causing its function to fail due to large radial compression force, it is necessary to appropriately reduce the radial compression force by adjusting the parameters of the fixed sealing ring 5.

[0059] Then, place the selected fixed sealing ring 5 into the fixed membrane 3, and ensure that the two groups of clamps on the fixed sealing ring 5 clamp the two rows of T-shaped protrusions 4 on the fixed membrane 3, compress the one-way valve device with a compressor and install it into the delivery catheter, which reaches the implanted target bronchial segment through the fiber bronchoscope.

[0060] Then, push the delivery catheter to slowly release the one-way valve device, first release the fixing component, release and fix the fixed sealing ring 5 in the carina of the bronchial segment, then move the delivery catheter slightly toward the distal end of the bronchial segment, and then gradually release the one-way valve component until the fixed sealing ring 5 presses the fixed membrane 3 and seals with the bronchial wall.

[0061] Finally, check the position of the fixed sealing ring 5 and the working status of the one-way valve 2. If everything is normal, the implantation is complete. If the one-way valve device needs to be removed, reach the implantation position of the one-way valve device through the fiber bronchoscope one-way valve grasping forceps 7, open the jaws, grasp the pull ring 6 with the grasping hook, and pull out the one-way valve device.

[0062] The present invention has the following advantages:

[0063] 1. The present invention replaces the inherent support structure of the current one-way valve with a replaceable and detachable fixed sealing ring. Therefore, the appropriate fixed sealing ring type can be selected according to the actual measured length of the bronchial segment to be implanted in the emphysema patient to adapt to patients with different bronchial segment lengths, so that all patients can receive bronchial one-way valve treatment, and the installation and removal methods are simple and quick, while also ensuring stability;

[0064] 2. The fixed sealing ring of the present invention is used in conjunction with the fixed membrane to replace the inherent support structure of the current one-way valve. The fixed sealing ring of appropriate size, shape and line width can be selected according to the actual measured diameter of the bronchial segment to be implanted in the patient with emphysema, so that the fixed sealing ring has a more appropriate radial force, avoiding excessive radial force causing bronchial wall granulation hyperplasia or too small radial force causing the one-way valve to fall off or cough up, making the one-way valve function ineffective, and reducing the patient's pain and economic burden;

[0065] 3. The fixed sealing ring contains a pull ring, which allows you to use a grasping forceps to hold the one-way valve more firmly and remove it. It is not easy to fall off during the removal process, which reduces the difficulty of removal and reduces the pain of the patient.

[0066] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A one-way flap device, characterized in that: include: One-way flap assembly and fixing assembly; The one-way flap assembly comprises: a protection bracket and a one-way flap located in the protection bracket, a coating is provided on the surface of the protection bracket and the coating is connected to the one-way flap; The fixing assembly includes: a fixing film and a fixing sealing ring, one side of the fixing film is connected to the covering film at the distal end of the protection bracket, and the other side extends toward the direction of the proximal end of the protection bracket to form an annular portion surrounding the distal end of the protection bracket; The inner surface of the annular portion is provided with two rows of T-shaped protrusions which are arranged circumferentially, staggered and evenly spaced. The fixed sealing ring is provided with two groups of clamping positions, which are respectively clamped on the two rows of T-shaped protrusions to press the annular portion against the inner wall of the bronchus.

2. A one-way flap device according to claim 1, characterized in that: The fixed sealing ring is a wavy ring structure, and each wave crest of the wavy ring structure constitutes one group of the clamping positions, and each wave trough constitutes another group of the clamping positions, and is respectively clamped on the two rows of T-shaped protrusions.

3. A one-way flap device according to claim 2, characterized in that: The number of wave crests and wave troughs of the wavy annular structure is the same as the number of wave troughs, and is consistent with the number of T-shaped protrusions in a single row; The number of wave crests of the wavy ring structure is 3 to 12, and the line width of the wavy ring structure is 0.1 to 0.3 mm.

4. A one-way flap device according to claim 1, characterized in that: The fixed sealing ring is a grid-like ring structure composed of diamond frames connected in sequence, and the corners on one side of each diamond frame constitute one group of the clamping positions, and the corners at the joints of each diamond frame constitute another group of the clamping positions, and are respectively clamped on the two rows of T-shaped protrusions.

5. A one-way flap device according to claim 4, characterized in that: The number of grids formed by the diamond-shaped frames in the fixed sealing ring is consistent with the number of the T-shaped protrusions in a single row; The number of grids formed by the diamond frames in the fixed sealing ring is 3 to 12, and the line width of the grid-shaped ring structure is 0.1 to 0.3 mm.

6. A one-way flap device according to claim 1, characterized in that: The fixed sealing ring includes a wave-shaped ring structure and a grid-shaped ring structure composed of diamond frames connected in sequence; The wave crests of the wavy annular structure form one group of the clamping positions, and one corner is selected at intervals from the bottom corners of the grid-like annular structure to form another group of the clamping positions, which are respectively clamped on the two rows of T-shaped protrusions.

7. A one-way flap device according to claim 6, characterized in that: The number of wave crests of the wavy annular structure is consistent with the number of the T-shaped protrusions in a single row, and the number of grids formed by the diamond frames in the grid-shaped annular structure is twice the number of the T-shaped protrusions in a single row; The number of wave peaks of the wavy ring structure and the number of grids formed by the diamond frames in the grid-like ring structure are 3 to 12, and the line width of the wavy ring structure and the line width of the grid-like ring structure are 0.1 to 0.3 mm.

8. A one-way flap device according to claim 1, 3, 5 or 7, characterized in that: The protective support is a hollow tubular structure, the one-way valve is located inside the hollow tubular structure, and the shape of the one-way valve includes but is not limited to a duckbill shape, a cross shape or a wave shape.

9. A one-way flap device according to claim 8, characterized in that: A pull ring is arranged on the fixed sealing ring, the pull ring is inclined toward the axis side of the fixed sealing ring, and the number of the pull rings is 2-4.

10. A one-way flap device according to claim 9, characterized in that: The fixing film is made of elastic polymer material; the protection bracket and the fixing sealing ring are elastic frames with shape memory formed by heat setting after laser cutting of nickel-titanium alloy tube or by laser welding of nickel-titanium alloy wire.

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