Improved one-way valve device

Abstract

The present application relates to an improved one-way valve device, including a support body and a diaphragm covering the support body, the diaphragm has a free edge that can be flexibly matched with the support body to control the degree of airway opening, the support body includes a plurality of support rods, one end of all the support rods converges, the other end is radially distributed and inclined toward the proximal side, the support body is a deformable mesh cover structure as a whole, and the mesh cover structure is expanded and opened toward the proximal side; the free edge is provided with an exhaust groove, the proximal side of the exhaust groove is open, and the diaphragm is also connected to a floating sheet arranged near the exhaust groove, and the exhaust groove can be closed or opened during the movement of the floating sheet. When the free edge is deformed radially inward, it will not be affected by the circumferential traction force of the free edge under the action of the exhaust groove, the free edge is more sensitive, the gap between the diaphragm and the inner wall of the airway is larger, and it is more conducive to the discharge of secretions under the premise of ensuring the airway blocking effect through the floating sheet.

Description

Technical Field

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

[0002] Chronic obstructive pulmonary disease (COPD) is an incurable disease with high morbidity and the third highest mortality rate worldwide. Common treatments include medication and lung volume reduction surgery (LVRS). The 2017 Global Initiative for Chronic Obstructive Pulmonary Disease (Gold Guidelines) update recommends endoscopic lung volume reduction (ELVR) as an option for patients with severe COPD, arguing that it is safer than LVRS and is particularly suitable for those who are not suitable for LVRS.

[0003] One-way valve implantation is the most widely reported ELVR method in recent years. Through ELVR, a one-way valve is inserted into the severely diseased lobar bronchial airway (hereinafter referred to as the airway). This valve blocks air from entering the treated lobe but allows exhalation of air within the blocked lobe, promoting collapse of emphysematous tissue. It is the preferred ELVR option for patients with severe COPD who lack significant lateral ventilation. Due to the high cost and poor effectiveness of drug treatments and the high risk, harm, and mortality associated with lung volume reduction surgery, one-way valve implantation has gained widespread acceptance. Existing one-way valves primarily include the duckbill EBV (Pulmonx) and the umbrella-shaped endobronchial valve (IBV) (Olympus). Compared to traditional surgical and drug treatments, one-way valves offer lower costs, less invasive surgery, and a simpler, less invasive, and lower-risk procedure. However, due to the complex bronchial airway environment, the two existing one-way valves may not be optimally effective in different airway configurations. Summary of the Invention

[0004] Based on this, it is necessary to provide an improved one-way valve device to address the above technical problems.

[0005] The present application provides an improved one-way valve device, comprising a support body and a diaphragm covering the support body, the diaphragm having a free edge that flexibly engages with the support body to control the degree of airway patency, the support body comprising a plurality of support rods, all of which converge at one end and radiate and tilt toward the proximal end at the other end, the support body as a whole being a deformable mesh structure that flares and opens toward the proximal end;

[0006] The free edge is provided with an exhaust groove, the proximal end of which is open. The diaphragm is further connected with a floating sheet arranged near the exhaust groove, and the floating sheet can close or open the exhaust groove during movement.

[0007] When the free edge deforms radially inward, it will not be affected by the circumferential traction of the free edge under the action of the exhaust groove. The free edge is more sensitive and has a larger deformation amount. The gap between the diaphragm and the inner wall of the airway is larger. On the premise of ensuring the airway blocking effect through the floating sheet, it is more conducive to the discharge of secretions.

[0008] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0009] Optionally, the one-way valve device further includes:

[0010] a first connecting member located at the center of the mesh structure, one end of all support rods being converged and fixed to the first connecting member, the first connecting member having an adapting structure for cooperating with the interventional delivery system;

[0011] An anchoring member is fixed to the first connecting member and is located at the distal end of the supporting body.

[0012] The setting of the connector facilitates the connection with the delivery system or auxiliary components, and also provides a hardware basis for adapting to different release methods; the anchor completes the relative fixation of the one-way valve device and the airway.

[0013] Optionally, all support rods and the first connecting member are fixed in a separate or integrated structure, and the adapting structure is a hook, a connecting hole, or an enlarged head.

[0014] The adapting structure realizes the mutual limitation between the interventional delivery systems, and can be released from each other when needed, so as to realize the delivery, release or recovery of the one-way valve device.

[0015] Optionally, the one-way valve device has a loading state for interventional delivery, a compressed state for recovery, and a released state for operation;

[0016] In the released state, the flared edge of the mesh cover structure is located on the proximal side of the first connecting member.

[0017] In the loaded state, the support bars converge radially inward, and the first connecting member is located in the area enclosed by the mesh structure, that is, it does not extend out of the proximal side of the mesh structure, thereby avoiding an increase in the overall length of the one-way valve device and ensuring sufficient compliance during the interventional bending process.

[0018] Optionally, the support rod has a detour portion extending distally at a central portion adjacent to the mesh cover structure.

[0019] The provision of the detour portion can avoid the first connecting member in space, thereby optimizing the extension trend of the support rod.

[0020] Optionally, in the loaded state, the detour portion remains folded.

[0021] The axial length of the one-way valve device is further reduced, making it applicable to a wider range of airways.

[0022] Optionally, the free edge passes over the flared edge of the mesh cover structure, and the passing portion forms a free band continuously distributed along the circumference of the support body.

[0023] The free edge is less affected by the structure of the supporting body, has a larger margin of motion, and is more sensitive to opening and closing.

[0024] Optionally, the width of the free band is 1.5 mm to 4 mm.

[0025] Optionally, the free bands are of equal width at the ends of the support rods.

[0026] Optionally, the thickness of the free band gradually decreases from the distal end to the proximal end.

[0027] Optionally, the exhaust slot is a slit extending in a straight line or gradually narrowing from the proximal side to the distal side.

[0028] Compared with slit extension, gradual narrowing can obtain a larger avoidance gap, which is more conducive to the discharge of secretions.

[0029] Optionally, the floating sheet is strip-shaped and extends along the busbar of the mesh structure. Along the length direction of the floating sheet, the area where the floating sheet matches the exhaust slot position is the working section, and the working section gradually becomes thinner in the area adjacent to the proximal side of the floating sheet.

[0030] It can make the floating piece more sensitive when it swings open.

[0031] Optionally, along the length direction of the floating sheet, the working section gradually becomes thinner from its own middle region toward the proximal end side of the floating sheet.

[0032] The sealing effect and the sensitivity of opening and closing are further enhanced.

[0033] Optionally, the fixed position of the floating sheet and the diaphragm is only at the distal end side of the corresponding exhaust groove;

[0034] The floating piece is aligned with the proximal edges of both the diaphragm.

[0035] The selection of the fixed position of the floating piece allows the floating piece to fully open the exhaust groove. In addition, alignment with the proximal edge of the diaphragm can avoid the floating piece being too short to completely close the exhaust groove, or the floating piece being too long and sagging to affect air tightness.

[0036] The recyclable one-way valve device of the present application improves the airway control effect while taking safety into consideration through structural improvement. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 This is a schematic diagram of the three-dimensional structure of a one-way valve device in one embodiment of the present application;

[0038] Figure 2a for Figure 1 Schematic diagram of the cooperation relationship between the diaphragm and the floating plate in the one-way valve device shown;

[0039] Figure 2b for Figure 2a Schematic diagram of the structure of mid-proximal side observation;

[0040] Figure 2c for Figure 2a Schematic diagram of the structure of mid-to-far side observation;

[0041] Figures 3a to 3c for Figure 1 Schematic diagrams of different angles of the one-way valve device after omitting the diaphragm shown in FIG;

[0042] Figure 4 This is a schematic structural diagram of an anchoring member in a one-way valve device according to an embodiment of the present application;

[0043] Figure 5 This is a schematic structural diagram of a one-way valve device in a loaded state according to an embodiment of the present application;

[0044] Figure 6 This is a schematic structural diagram of a one-way valve device in a compressed state according to an embodiment of the present application;

[0045] The reference numerals in the figures are described as follows:

[0046] 100, airway; 110, traction member; 111, recovery pull ring; 120, support tube; 121, fixing groove; 130, recovery sleeve;

[0047] 300, one-way valve device; 301, proximal end; 302, distal end;

[0048] 310. First connecting member; 311. Recovery hook;

[0049] 320, support body; 321, support rod; 322, round cake; 323, roundabout portion;

[0050] 330, diaphragm; 331, free edge; 332, free band; 333, exhaust groove; 334, point;

[0051] 340, floating piece; 341, fixed end; 342, movable end;

[0052] 400, anchoring member; 410, anchor rod; 411, main anchor spike; 412, auxiliary anchor spike; 413, inner connecting ring; 420, anchor rod; 421, working surface; 422, protrusion; 423, connecting arm. DETAILED DESCRIPTION

[0053] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0055] In this application, the terms "first," "second," etc. are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly indicate the number or order of the technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0056] In this application, the terms "comprises" and "comprising" and any variations thereof are intended to cover non-exclusive inclusions, for example, a system, product or apparatus comprising a list of elements is not necessarily limited to those elements expressly listed but may include other elements not expressly listed or inherent to such products or apparatuses.

[0057] The duckbill bronchial valve EBV in the prior art is composed of a support mesh and two valves located in the middle of the support mesh. When placed in the airway, it achieves one-way ventilation and blocks gas from entering the lung lobe to be treated through the movement of the two valves. The specific way to achieve one-way ventilation is: the two valves open during exhalation and close during inhalation. However, the two valves are located in the middle of the support mesh, which is not conducive to the discharge of secretions from the bronchi. There is also an umbrella-shaped endobronchial valve IBV, which includes an umbrella-shaped support frame covered with a layer of diaphragm and a diaphragm for forming an airway blockage. In order to facilitate intervention and recovery, a connection part for recovery extends from the middle of the umbrella-shaped support frame, and the axial length of the connection part exceeds the umbrella-shaped support frame. The connection part affects the entire umbrella-shaped endobronchial valve, making it difficult to recover. In addition, the effect of secretion discharge from the bronchi during intervention with the umbrella-shaped endobronchial valve IBV is not good enough. When secretions are discharged, the diaphragm deforms radially inward, creating a clearance gap between the diaphragm and the inner wall of the airway to allow secretions to escape. However, because the diaphragm's overall posture during radial inward deformation is constrained by the umbrella-shaped support frame, the clearance gap is insufficient, hindering the discharge of secretions and hindering the recovery of affected tissue.

[0058] See also Figure 1 and Figure 2a An embodiment of the present application provides an improved one-way valve device 300, including a support body 320 and a diaphragm 330 covering the support body 320. The diaphragm 330 has a free edge 331 relative to the support body 320 that can be flexibly fitted to control the degree of airway opening. The support body 320 is a deformable mesh structure as a whole, and the mesh structure is flared and open toward the proximal side; the free edge 331 is provided with an exhaust groove 333, and the proximal side of the exhaust groove 333 is open. The diaphragm 330 is also connected to a floating sheet 340 arranged near the exhaust groove 333, and the floating sheet 340 can close or open the exhaust groove 333 during movement.

[0059] The one-way valve device also includes a first connecting member 310 and an anchoring member 400. The first connecting member 310 assists in the interventional delivery and recovery of the one-way valve device. The anchoring member 400 is fixed to the first connecting member 310 and is located on the distal side of the support body 320, thereby achieving relative fixation of the one-way valve device and the inner wall of the airway.

[0060] In the various embodiments of the present application, the structural features of the support body 320, the diaphragm 330 and the anchor 400 are assumed to be in a released state unless otherwise specified. Deformable means that the one-way valve device can be compressed and stored in the interventional delivery system during interventional delivery or retrieval. The proximal end 301 or the proximal side described in the various embodiments of the present application refers to the end or side that is relatively close to or facing the surgical operator during intervention, and the distal end 302 or the distal side refers to the end or side that is relatively far away from or facing away from the surgical operator during intervention. The radial dimension of the proximal side of the support body 320 is larger than the radial dimension of the distal side, and the radial dimension changes gradually. The mesh cover structure itself has a large number of hollow areas, which can adapt to radial scaling and can be formed by weaving or cutting. Overall, the mesh cover structure is semi-open, that is, the support body 320 is open toward the proximal side as a whole.

[0061] The diaphragm 330 in this embodiment is made of a soft material and is coated on the mesh structure of the support body 320. The anchor 400 is anchored to the inner wall of the airway 100 to secure the one-way valve device. The free edge 331 is located at the periphery of the diaphragm. The free edge 331 controls the degree of opening of the airway 100 in the following manner: during inspiration, gas flows from the proximal end 301 to the distal end 302, and the diaphragm 330 is subjected to radial force outward, causing the free edge 331 to move closer to the inner wall of the airway 100, forming a barrier and preventing further gas from entering. During exhalation, gas flows from the distal end 302 to the proximal end 301, and internal gas and secretions cause the free edge 331 to be subjected to radial force inward and deform, forming an escape gap between the diaphragm 330 and the inner wall of the airway 100, allowing internal gas and secretions to be discharged through the gap between the diaphragm 330 and the inner wall of the airway 100, thereby achieving a one-way ventilation function. The diaphragm 330 covers the portion of the support body 320 close to the distal end, and the free edge 331 passes over the flared edge of the mesh structure and the free band 332 that is partially formed and continuously distributed along the circumference of the support body 320 .

[0062] The mesh structure itself is a grid structure with hollowed-out areas, or multiple radiating rods. The flared edge corresponds to the nearest side of the grid or the proximal end of the rod. The free band 332 is an annular band. Along the axial direction of the support body, the width L of the free band 332 is approximately 2 mm, for example, 1.5 mm to 4 mm.

[0063] In this embodiment, during inhalation or exhalation, the free edge 331 is less affected by the support body 320, allowing for greater mobility and more responsive opening and closing of the free edge 331. The outer diameter of the mesh structure at the flared edge is smaller than the circumscribed diameter of the anchor. When the airway at this location is approximately cylindrical in shape, the anchor and the airway inner wall support and position will slightly reduce the abutment force between the flared edge of the mesh structure and the airway inner wall, thus providing the necessary space for the free band 332 to float.

[0064] To further ensure the agility of the free band 332's movement, the thickness of the free band 332 can gradually decrease from the flared edge of the mesh structure toward the proximal end. Without considering airway compression and gravity, the free band 332 has a free state, which can also be understood as the intended initial shape during processing. In this free state, the free band 332 has a more pronounced outward expansion tendency relative to the adjacent support body portion.

[0065] Furthermore, since the free edge 331 is provided with an exhaust groove 333, during inhalation, the exhaust groove 333 is closed by the floating sheet 340, which does not affect the blocking effect of the diaphragm 330 on the airway 100; during exhalation, the floating sheet 340 opens the exhaust groove 333, and the radial inward deformation of the free edge 331 is not affected by the circumferential traction of the free edge 331. The free edge 331 is more sensitive and has a larger deformation amount. The gap between the diaphragm 330 and the inner wall of the airway 100 is larger, which is more conducive to the discharge of secretions. Through the above structural design, the one-way valve device can stably achieve one-way ventilation in the affected area after being implanted in the lungs. By preventing external air from entering and discharging internal waste gas, the lung capacity of the damaged area is reduced, the damage caused by excessive expansion of the damaged area is alleviated, and the purpose of reducing lung capacity and inhibiting excessive expansion of the lung is achieved, thereby improving respiratory function. It can be understood that since the exhaust groove 333 makes it easier for internal gas or secretions to be discharged, the diaphragm 330 in this embodiment can be thicker than the conventional prior art.

[0066] See also Figure 1 and Figure 2a The exhaust groove 333 extends along the generatrix of the support body 320. In the axial direction of the support body 320, the length D1 of the exhaust groove 333 is 25% to 65% of the length of the support body 320, for example, 30%. Furthermore, the exhaust groove 333 is a straight slit or gradually narrows from the proximal end to the distal end.

[0067] The support body 320 appears as a rotating body with a generatrix and an axis. The axis roughly coincides with the line connecting the proximal end 301 and the distal end 302. The venting slot 333 is located on the proximal side of the diaphragm 330 and extends toward the distal end of the diaphragm 330, reaching a length D1. The floating sheet 340 is strip-shaped and extends along the generatrix of the mesh structure. Along the length of the floating sheet 340, the area where the floating sheet 340 aligns with the venting slot 333 constitutes the working section. This working section gradually becomes thinner near the proximal end of the floating sheet 340. Furthermore, along the length of the floating sheet 340, the working section gradually becomes thinner from its mid-section toward the proximal end of the floating sheet 340, further enhancing the sealing effect and opening and closing sensitivity.

[0068] See also Figure 1 and Figure 2aThe floating plate 340 and the diaphragm 330 are fixed at the distal end of the corresponding exhaust slot 333. Specifically, the floating plate 340 includes a fixed end 341 and a movable end 342, which are located at the two ends in the longitudinal direction. The working section is the portion of the floating plate 340 adjacent to the fixed end 341. The floating plate 340 is entirely located radially inward of the diaphragm 330. The fixed end 341 is relatively fixed to the diaphragm 330, and the movable end 342 is attached to and seals the diaphragm 330 during inhalation and moves away from the diaphragm 330 during exhalation, creating a clearance. The fixed end 341 can be fixed to the inner side of the diaphragm 330, for example, by adhesive bonding. Furthermore, the proximal edges of the floating plate 340 and the diaphragm 330 are aligned, and the floating plate 340 does not extend beyond the proximal side of the diaphragm 330. The length of the floating piece 340 in the axial direction is greater than the length D1 of the exhaust groove 333 to ensure the stability of the fixing between the floating piece 340 and the diaphragm 330 .

[0069] In the axial direction of the support body, the distal end of the vent groove 333 is located in the central region of the diaphragm 330. Specifically, the length of the projection of the diaphragm 330 on the support body axis is D2, and the midpoint of the projection is point 334. The distal end of the vent groove 333 is close to the axial position of point 334, for example, the distance is less than or equal to 15% of D2.

[0070] Regarding the number of venting slots, each free edge 331 defines an venting slot 333 between any two adjacent support rods 321 along the circumference of the support body 320. Multiple venting slots 333 are provided, and the plurality of venting slots 333 are spatially symmetrical. Furthermore, the number of venting slots 333 is half the number of support rods 321 or the same as the number of support rods 321. It will be appreciated that providing multiple venting slots 333 circumferentially can avoid or reduce circumferential blind spots.

[0071] See also Figure 3a The support body 320 includes a plurality of support rods 321, one end of all the support rods converges to the center of the mesh structure, and the other end radiates outward and tilts toward the proximal side. For example, one end of the support rod 321 is located in the center, and the other end radiates outward and tilts toward the proximal side from the overall extension trend. The extension path of each support rod is a smooth curve, and the number of support rods is 4 to 10, for example, the number of support rods is 6 or 8. The support rods ensure the overall shape of the support body 320 and the close fit between the diaphragm 330 and the inner wall of the airway 100. In terms of material, the support rods are made of elastic memory metal material.

[0072] Furthermore, the proximal ends of the support rods are defined as the distal ends, and the distal ends of the support rods have rounded ends. Together, the distal ends of the support rods form the edge of the mesh structure of the support body 320. It will be appreciated that this rounded end structure increases the area of ​​attachment between the support rods 321 and the diaphragm 330. Specifically, the rounded end structure does not require a standard circular or spherical shape; it simply means that the proximal end of the rounded end structure extends roughly along an arc to avoid damage to the diaphragm 330. The actual shape of the rounded end structure can be, for example, the circular disc 322 shown in the figure.

[0073] See also Figure 3a The improved one-way valve device also includes a first connecting member 310, which is located in the center of the mesh structure. One end of all support rods converges and is fixed to the first connecting member 310. The first connecting member 310 has an adapter structure for cooperating with the interventional delivery system.

[0074] Furthermore, all support rods and the first connecting member 310 are fixed in a separate or integrated structure, and the adapting structure is a hook, a connecting hole, or an enlarged head. For example, the first connecting member 310 is a hollow round tube, and the adapting structure on the first connecting member 310 is a recovery hook 311.

[0075] The support rod 321 has a detour portion 323 extending distally near the center of the mesh structure. The support rod 321 extends from the center toward the distal end 302, then smoothly curves in a nearly arc-shaped manner before extending toward the proximal end 301. This curve is the detour portion 323. Detour portion 323 expands radially outward during the curve.

[0076] See also Figure 3a The anchor 400 comprises multiple radially distributed anchor rods 410. Each anchor rod converges at one end and is fixed to a third connector. The other end extends radially outward from the support body and terminates in a bifurcated, multi-stranded anchor spike. The center of the radial distribution of the anchor 400 is the end of the anchor rod 410 fixed relative to the first connector. The bifurcated, multi-stranded anchor spike acts on the inner wall of the airway 100 to position the anchor 400. For example, each anchor rod 410 has a primary anchor spike 411 and a secondary anchor spike 412. The primary anchor spike 411 penetrates the inner wall of the airway 100 perpendicular to the axis of the support body 320, providing overall positioning. The secondary anchor spike 412 abuts against the inner wall of the airway 100 to prevent excessive penetration and rollover. Specifically, the primary anchor spike 411 extends perpendicularly to the section of the inner wall of the airway 100 where the support body 320 is located, while the secondary anchor spike 412 extends perpendicularly to the primary anchor spike 411.

[0077] See also Figure 3a The third connecting member is integrally formed with the first connecting member 310 or is fixedly nested therewith. For example, the third connecting member is an inner connecting ring 413, which is nested and fixed to the first connecting member 310 or is fixedly welded thereto.

[0078] In one embodiment, see Figure 4 The anchor 400 includes multiple radially distributed anchor rods 420. Each anchor rod 420 extends radially outward from the support body 320 and has an active surface 421 that engages the inner wall of the airway 100. The active surface 421 is equipped with a protruding friction-enhancing component. The anchor rods are spatially symmetrical and axially symmetrical. There are four to eight anchor rods, for example, six. The active surface 421 engages the inner wall of the airway 100, meaning that the active surface 421 maintains contact with the inner wall of the airway 100. The friction-enhancing component is fixed to the active surface 421 and protrudes radially outward to achieve frictional fixation between the active surface 421 and the airway 100. Compared to anchor barb fixation, this embodiment avoids damage to the airway 100 and reduces the possibility of inflammation while ensuring effective fixation and reducing the risk of rollover. The friction-enhancing component can be, for example, a plurality of protrusions 422 arranged in a sequence. Each protrusion is spherical and convex as much as possible to facilitate positioning. The arrangement may be, for example, a linear arrangement, a triangular arrangement, or an array arrangement.

[0079] In one embodiment, the support body 320 and the anchor 400 can be deformed or flexibly connected. For example, the first connector 310 and the inner connecting ring 413 are connected and fixed by a memory wire or a sea wave tube, allowing the axis of the support body 320 to form an angle with the axis of the anchor 400 relative to each other, and the overall posture is adaptive, making it applicable to a wider range of airways 100. Specifically, when the length of the one-way valve is long, the sealing effect in the curved airway is not good. Compared with the relatively fixed connection between the anchor 400 and the support body 320, this embodiment can adapt to complex airway 100 structures, can achieve the sealing of curved airways, and further enhance flexibility.

[0080] In one embodiment, see Figure 4 As shown in the figure, each anchor rod is partly connected to a connecting arm 423. One end of the connecting arm 423 is fixedly connected to the inner connecting ring 413, and the other end is fixedly connected to the opposite side of the active surface 421 (the opposite side of the active surface 421 that contacts the inner wall of the airway 100). This allows each anchor rod to be curled into a closed loop structure, improving stability and further ensuring the effectiveness of the friction-increasing component.

[0081] To disclose the interventional delivery and retrieval process of the one-way valve device, in one embodiment, see Figure 3a 、 Figure 5 ,and Figure 6 The one-way valve device has a release state during operation, a loading state for interventional delivery, and a compression state during retrieval.

[0082] See also Figure 6The opening angle of the retrieval hook 311 is inclined toward the distal end of the support body 320. The side wall of the first connecting member 310 is cut, and its head position forms the retrieval hook 311 as a whole. The interventional delivery system may include a traction member 110, the distal end of which is provided with a retrieval pull ring 111. The retrieval pull ring 111 acts on the retrieval hook 311 to enable the interventional delivery system to retract the one-way valve device. The interventional delivery system also includes a support tube 120, which is movably mounted on the outside of the traction member 110. The distal end of the support tube 120 is provided with a fixing groove 121, which engages with the retrieval pull ring 111. The support tube 120 is pressed against the first connecting member 310 in the distal direction. On the one hand, the support tube 120 can limit the radial position of the retrieval pull ring 111 to maintain a stable connection between the retrieval pull ring 111 and the first connecting member 310, and can also provide the necessary axial driving force. The operation of the one-way valve device is achieved through the cooperation between the recovery sleeve 130, the support tube 120 and the recovery pull ring 111.

[0083] In the loaded state, the flared edge of the mesh structure is radially gathered inwardly within the recovery sleeve 130, and the detour portion 323 remains folded.

[0084] During interventional delivery, the traction member 110, support tube 120, retrieval cannula 130, and the loaded one-way valve device are transported to a designated location. The one-way valve device is then released through the distal end of the retrieval cannula 130. After the retrieval cannula 130 is released from its restraints, the anchor 400 and the mesh structure return to their released state. The anchor 400 is fixed relative to the airway 100, and the mesh structure and diaphragm 330 together form a seal to block the airway 100. After the release is complete, the support tube 120 releases the radial position restraint on the retrieval ring 111, allowing the retrieval ring 111 to move distally and exit from the retrieval hook 311.

[0085] When recovery is required, the support body 320 and the anchor 400 are sequentially received into the recovery sleeve 130 through the relative movement of the one-way valve device and the recovery sleeve 130. The edge of the recovery sleeve 130 acts on the inner side of the smooth turning of the detour portion 323, and the detour portion 323 further guides each support rod to be straightened. The one-way valve device is received into the recovery sleeve 130, and the detour portion 323 remains straightened. Figure 6 As shown, in the compressed state, the anchor rod 410 is converged, and the support rod 321 is converged and surrounded by the outer periphery of the anchor rod 410.

[0086] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[0087] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[0088] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art may make various modifications and improvements without departing from the spirit of the present application, and such modifications and improvements are all within the scope of protection of the present application.

Claims

1. An improved one-way flap device, comprising a support body and a diaphragm covering the support body, wherein the diaphragm has a free edge that is movable relative to the support body to control the degree of airway opening, characterized in that: The support body comprises a plurality of support rods, one end of all the support rods converges, the other end of the support rods is radially distributed and inclined toward the proximal end side, and the support body as a whole is a deformable mesh cover structure, and the mesh cover structure is expanded and opened toward the proximal end side; The free edge is provided with an exhaust groove, the proximal side of the exhaust groove is open, and the diaphragm is also connected to a floating sheet arranged near the exhaust groove, and the exhaust groove can be closed or opened during the movement of the floating sheet.

2. The improved one-way flap device according to claim 1, characterized in that: The one-way flap device also includes: A first connecting member is located at the center of the mesh structure, one end of all the support rods converge and are fixed to the first connecting member, and the first connecting member has an adapting structure for cooperating with the interventional delivery system; An anchoring member is fixed to the first connecting member and is located at the distal end side of the supporting body.

3. The improved one-way flap device according to claim 2, characterized in that: All support rods and the first connecting member are fixed in a separate body or in an integrated structure, and the adapting structure is a hook, a connecting hole, or an enlarged head.

4. The improved one-way flap device according to claim 2, characterized in that: The one-way flap device has a loading state for interventional delivery, a compressed state for recovery, and a released state for operation; In the released state, the flared edge of the mesh cover structure is located at the proximal side of the first connecting member.

5. The improved one-way flap device according to claim 1, characterized in that: The support rod has a detour portion extending from the distal end at a central portion adjacent to the mesh cover structure; In the loaded state, the detour portion remains folded.

6. The improved one-way flap device according to claim 1, characterized in that: The free edge passes over the expanded edge of the mesh cover structure, and the passing portion forms a free belt that is continuously distributed along the circumference of the support body.

7. The improved one-way flap device according to claim 1, characterized in that: The exhaust groove is a slit extending in a straight line or gradually narrowing from the proximal side to the distal side.

8. The improved one-way valve device according to any one of claims 1 to 7, characterized in that: The floating sheet is strip-shaped and extends along the busbar of the mesh structure. Along the length direction of the floating sheet, the area where the floating sheet matches the exhaust slot position is the working section, and the working section gradually becomes thinner in the area adjacent to the proximal side of the floating sheet.

9. The improved one-way flap device according to claim 8, characterized in that: Along the length direction of the floating sheet, the working section gradually becomes thinner from its middle region toward the proximal end side of the floating sheet.

10. The improved one-way flap device according to claim 9, characterized in that: The fixed position of the floating sheet and the diaphragm is only at the distal end side of the corresponding exhaust groove; The floating sheet is aligned with the proximal edges of both the diaphragm.

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