One-way valve device

Abstract

The present application relates to a 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 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 described in the present application 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 and has a larger deformation amount, and the gap between the diaphragm and the inner wall of the airway is larger, which is more conducive to the discharge of secretions while 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 a one-way valve device. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is an incurable disease with a high incidence and the third highest mortality rate in the world. Common treatments include drug therapy and lung volume reduction surgery (LVRS). The 2017 Global Initiative for Chronic Obstructive Pulmonary Disease (Gold Guidelines) update recommends that endoscopic lung volume reduction (ELVR) can be selectively applied to patients with severe COPD, which is safer than LVRS, especially for people who are not suitable for LVRS.

[0003] One-way valve implantation is the most reported ELVR method in recent years. It is a method of inserting a one-way valve into the severely diseased lobar bronchial airway (hereinafter referred to as the airway) through ELVR to block the gas from entering the treated lobe, but allow the air in the blocked lobe to be exhaled, promote the collapse of emphysematous tissue, and is the preferred ELVR solution for patients with severe COPD without obvious lateral ventilation. Due to the high price and poor effect of drug treatment, and the high risk of lung volume reduction surgery, great harm to the human body and high mortality rate, the one-way valve implantation is widely recognized. The existing one-way valves mainly include duckbill bronchial valve EBV (Pulmonx) and umbrella-shaped endobronchial valve IBV (Olympus). Compared with traditional surgery and drug treatment, the one-way valve is cheaper, and the surgery causes less damage to the human body. The surgery is simple, with small wounds and low risks. However, due to the complex airway environment of the bronchus, the two existing one-way valve products have poor effects under different airway structures. Summary of the invention

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

[0005] The one-way valve device of the present application includes a support body and a diaphragm covering the support body, the diaphragm has a free edge that can be flexibly fitted with the support body to control the degree of airway opening, 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.

[0006] 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.

[0007] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

[0008] Optionally, the one-way flap device has a distal side and a proximal side opposite to each other, and the support body is a deformable cage structure as a whole, and the cage structure converges in shape at the distal end and the proximal end;

[0009] The one-way flap device also includes:

[0010] An anchor, fixed to the distal end of the support body;

[0011] The first connecting member is fixed to the proximal end of the support body, and the first connecting member has an adapting structure for cooperating with the interventional delivery system.

[0012] The mesh cage structure design of the support body makes the support force on the inner wall of the airway more stable, and the overall shape changes gradually and controllably when subjected to force, making it easy to position and recover the interventional delivery.

[0013] Optionally, the diaphragm is coated on a portion of the support body close to the distal end, and the free edge is located at the periphery of the support body and adjacent to a region with the largest outer diameter of the support body.

[0014] The diaphragm and the free edge enable internal gas and secretions to be discharged from the gap between the diaphragm and the inner wall of the airway, thereby achieving a one-way ventilation function.

[0015] Optionally, the support body includes a plurality of support rods, one end of all the support rods converge to the first connecting member, and the other end converge to the second connecting member, and the anchor is fixed to the second connecting member.

[0016] The overall shape of the support body and the close fit between the diaphragm and the inner wall of the airway are ensured. The two connectors are arranged to facilitate the connection with the delivery system or auxiliary components, and also provide a hardware basis for adapting to different release methods.

[0017] 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.

[0018] The adapting structure realizes the mutual limitation between the intervention delivery systems, and can be released from each other when necessary, so as to realize the delivery, release or recovery of the one-way valve device.

[0019] Optionally, the one-way valve device has a compressed state for interventional delivery and a released state during operation. Relative to the released state, the cage structure is radially contracted in the compressed state, and the distal end and the proximal end of the support body are further away from each other.

[0020] It can avoid compression and radial stacking into a multi-layer structure, reduce the overall outer diameter, and improve compliance during interventional delivery.

[0021] Optionally, in the circumferential direction of the support body, the free edge is provided with an exhaust groove at a position between any two adjacent support rods.

[0022] A plurality of exhaust slots are arranged in the circumferential direction, so as to avoid or reduce the circumferential dead angle area.

[0023] Optionally, the exhaust groove extends along the generatrix direction of the support body;

[0024] In the axial direction of the support body, the length of the exhaust groove is 25% to 65% of the length of the support body.

[0025] The appropriate length of the exhaust groove can ensure the sensitivity of exhaust and reduce the material or strength requirements of the floating sheet.

[0026] Optionally, the exhaust groove is a slit extending in a straight line or gradually narrowing from the proximal side to the distal side.

[0027] Compared with slit extension, gradual narrowing can obtain a larger avoidance gap, which is more conducive to the discharge of secretions.

[0028] Optionally, the fixing positions of the floating sheet and the diaphragm are located at the distal end side of the corresponding exhaust groove.

[0029] This allows the floating piece to have greater freedom when swinging open.

[0030] Optionally, the floating sheet and the proximal edges of the diaphragm are aligned.

[0031] The alignment of the proximal edges of the two can avoid the situation where the floating sheet is too short to completely close the exhaust groove, or the floating sheet is too long and droops to affect the air tightness.

[0032] 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

[0033] 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;

[0034] Figure 2 for Figure 1 A schematic diagram of the matching relationship between the diaphragm and the floating plate in the one-way valve device shown;

[0035] Figure 3a to Figure 3c for Figure 1 Schematic diagrams of different angles after omitting the diaphragm in the one-way flap device shown;

[0036] Figure 4 This is a schematic diagram of the three-dimensional structure of a one-way valve device in one embodiment of the present application;

[0037] Figure 5 This is a schematic diagram of the structure of a one-way flap device in a semi-compressed state in one embodiment of the present application;

[0038] Figure 6 This is a schematic diagram of the structure of a one-way flap device in a compressed state in one embodiment of the present application;

[0039] The reference numerals in the figures are described as follows:

[0040] 100, airway; 110, traction piece; 111, recovery pull ring; 120, support tube; 121, fixing groove; 130, recovery sleeve;

[0041] 200, one-way flap device; 210, first connecting member; 211, recovery hook;

[0042] 220, support body; 221, proximal end; 222, distal end; 223, support rod;

[0043] 230, diaphragm; 231, free edge; 232, exhaust groove; 233, point;

[0044] 240, floating piece; 241, fixed end; 242, movable end;

[0045] 250, external connecting ring;

[0046] 400, anchoring member; 410, anchor rod; 411, main anchor thorn; 412, auxiliary anchor thorn; 413, inner connecting ring;

[0047] 420, anchor rod; 421, action surface; 422, protrusion; 423, connecting arm;

[0048] X1, radial dimension; X2, axial dimension. DETAILED DESCRIPTION

[0049] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0051] In this application, the terms "first", "second", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number or order of the indicated technical features. 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, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0052] In this application, the terms "comprises" and "has" and any variations thereof are intended to cover non-exclusive inclusions, for example, a system, product or device comprising a series of units is not necessarily limited to those units explicitly listed, but may include other units not explicitly listed or inherent to these products or devices.

[0053] The duckbill bronchial valve EBV in the prior art is composed of a support net and two valves located in the middle of the support net. When placed in the airway, it realizes 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 in the middle of the support net, 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. The umbrella-shaped endobronchial valve IBV is an open-ended structure, so its stability in the airway needs to be improved. In order to facilitate intervention and recovery, a connection part for recovery is extended 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, which is not easy to recover. In addition, the effect of secretion discharge from the bronchus during intervention of the umbrella-shaped endobronchial valve IBV is not good enough. When secretions are discharged, the diaphragm deforms radially inward, and a clearance gap is formed between the diaphragm and the inner wall of the airway to avoid secretions. However, since the overall posture of the diaphragm is limited by the umbrella-shaped support frame when it deforms radially inward, the clearance gap is not large enough, which affects the discharge of secretions and is not conducive to the recovery of lesion tissue.

[0054] See also Figure 1 An embodiment of the present application provides a one-way valve device 200, including a support body 220 and a diaphragm 230 covering the support body 220. The diaphragm 230 has a free edge 231 relative to the support body 220 that can be flexibly matched to control the degree of opening of the airway 100. The free edge 231 is provided with an exhaust groove 232, and the proximal side of the exhaust groove 232 is open. The diaphragm 230 is also connected to a floating sheet 240 arranged near the exhaust groove 232, and the floating sheet 240 can close or open the exhaust groove 232 during movement.

[0055] In each embodiment of the present application, the structural features of the support body 220, the diaphragm 230 and the anchor 400 are assumed to be in a released state unless otherwise specified. The released state is also called a predetermined state, in which the overall posture of the one-way valve device changes when a force is applied. The proximal end or proximal side described in each embodiment of the present application refers to an end or side that is relatively close to the human oral cavity during intervention, and the distal end or distal side refers to an end or side that is relatively far away from the human oral cavity during intervention. The diaphragm 230 in this embodiment is made of soft material. The diaphragm 230 is coated on the part of the support body 220 close to the distal side, and the free edge 231 is located at the periphery of the support body 220. When the one-way valve device reaches the predetermined position in the airway 100, the free edge 231 controls the degree of opening of the airway 100 in the following manner: during inhalation, the gas flows from the proximal end 221 to the distal end 222, and the diaphragm 230 is subjected to force radially outward, so that the free edge 231 is closer to the inner wall of the airway 100, forming a barrier, and the gas cannot continue to enter; during exhalation, the gas flows from the distal end 222 to the proximal end 221, and the internal gas and secretions cause the free edge 231 to be subjected to force and deform radially inward, and a gap is formed between the diaphragm 230 and the inner wall of the airway 100. Furthermore, since the free edge 231 is provided with an exhaust groove 232: during inhalation, the exhaust groove 232 is closed by the floating sheet 240, which will not affect the blocking effect of the diaphragm 230 on the airway 100; during exhalation, the floating sheet 240 opens the exhaust groove 232, and the radial inward deformation of the free edge 231 will not be affected by the circumferential traction force of the free edge 231. The free edge 231 is more sensitive and has a larger deformation amount. The gap between the diaphragm 230 and the inner wall of the airway 100 is larger, which is more conducive to the discharge of secretions.

[0056] Through the above structural design, the one-way valve device can stably achieve one-way ventilation in the lesion area after being implanted in the lung, thereby reducing the lung capacity and inhibiting lung over-expansion, thereby improving the respiratory function. It can be understood that since the exhaust groove 232 makes it easier for internal gas or secretions to be discharged, the diaphragm 230 in this embodiment allows a thicker thickness to be used compared to the conventional prior art.

[0057] In order to achieve the maximum blocking effect on the airway 100, the free edge 231 is located in the area adjacent to the support body 220 with the largest outer diameter. Since the area with the largest outer diameter of the support body 220 fits the airway 100 best, the maximum effect can be obtained.

[0058] To explain the function and effect of the exhaust slot 232, see Figure 1 and Figure 2The exhaust groove 232 extends along the generatrix direction of the support body 220; in the axial direction of the support body 220, the length D1 of the exhaust groove 232 is 25% to 65% of the length of the support body 220 (i.e., the axial dimension X2), for example, it can be 30%. Furthermore, the exhaust groove 232 is a straight-line slit or gradually narrows from the proximal side to the distal side.

[0059] The support body 220 is a rotating body with a generatrix and an axis in space. The axis is roughly coincident with the line connecting the proximal end 221 and the distal end 222. The exhaust groove 232 is opened on the proximal side of the diaphragm 230 and extends toward the distal side of the diaphragm 230 until it reaches the length D1. The floating sheet 240 is strip-shaped and extends along the generatrix of the mesh cage structure. Along the length direction of the floating sheet 240, the area where the floating sheet 240 matches the exhaust groove 232 is the working section, and the working section gradually becomes thinner in the area adjacent to the proximal side of the floating sheet 240. Furthermore, along the length direction of the floating sheet 240, the working section gradually becomes thinner from the middle area of ​​itself to the proximal side of the floating sheet 240. The blocking effect and the sensitivity of opening and closing are further enhanced.

[0060] To further explain the function and effect of the exhaust slot 232, see Figure 1 and Figure 2 , the fixed position of the floating sheet 240 and the diaphragm 230 is at the distal side of the corresponding exhaust groove 232. Specifically, the floating sheet 240 includes a fixed end 241 and a movable end 242, the fixed end 241 and the movable end 242 are at the two ends in the length direction, and the working section is the part of the floating sheet 240 adjacent to the fixed end 241. The floating sheet 240 is located on the radial inner side of the diaphragm 230 as a whole, the fixed end 241 is relatively fixed to the diaphragm 230, and the movable end 242 is attached to and closes the diaphragm 230 as the human body inhales, and is away from the diaphragm 230 as the human body exhales, and a clearance gap is formed. The fixing method of the fixed end 241 can be, for example, bonding to the inner side of the diaphragm 230 by adhesive. Further, the proximal edges of the floating sheet 240 and the diaphragm 230 are aligned, and the floating sheet 240 does not exceed the proximal side of the diaphragm 230. The length of the floating sheet 240 in the axial direction is greater than the length D1 of the exhaust groove 232 to ensure the stability of the fixing of the floating sheet 240 and the diaphragm 230 .

[0061] In the axial direction of the support body, the distal end of the exhaust groove 232 is located in the middle area of ​​the diaphragm 230. Specifically, the length of the projection line segment of the diaphragm 230 on the axis of the support body is D2, and the midpoint of the projection line segment is point 233. The distal end of the exhaust groove 232 is close to the axial position of point 233, for example, the distance is less than or equal to 15% of D2.

[0062] Further, the diaphragm 230 and the support rod 223 have a relative positional relationship. Along the axial direction of the support body 220, the free edge 231 is located in the middle area of ​​the support body 220. The middle area of ​​the support body 220 refers to the area with the largest outer diameter of the support body 220. In order to achieve a more secure fixation of the diaphragm 230 relative to the support body 220, further, the free edge 231 of the diaphragm 230 passes over the area with the largest outer diameter of the support body 220.

[0063] To reveal the structural features of the one-way valve device, see Figure 1 The one-way valve device has a distal side and a proximal side opposite to each other, and the support body 220 is a deformable cage structure as a whole, and the cage structure converges in shape at the distal end 222 and the proximal end 221. The one-way valve device also includes an anchor and a first connector 210. The anchor is fixed to the distal end 222 of the support body 220; the first connector 210 is fixed to the proximal end 221 of the support body 220, and the first connector 210 has an adapting structure for cooperating with the interventional delivery system.

[0064] In this embodiment, the support body 220 is deformable as a whole, which means that it can be compressed and stored in the interventional delivery system during interventional delivery or retrieval. Specifically, the change trends of the axial dimension X2 and the radial dimension X1 of the cage structure are negatively correlated. For example, it begins to deform under the radial inward force in the predetermined forming state, and the axial dimension X2 increases during the deformation process, while the radial dimension X1 decreases at the same time. The first connecting member 210 cooperates with the interventional delivery system, which means that during interventional delivery and retrieval, the interventional delivery system acts on the first connecting member 210 to send the one-way valve device to a predetermined position and withdraw it from a predetermined position. In other words, the adapter structure is used to achieve a detachable connection, and is used for the interventional delivery system to push and withdraw the one-way valve device through the first connecting member 210.

[0065] The support body 220 of the one-way valve device in this embodiment has a cage structure as a whole and converges in shape at the distal and proximal ends, so the overall shape is roughly spindle-shaped.

[0066] The one-way valve device in this embodiment has the following effects: first, the overall structure is more stable, and the support force on the inner wall of the airway 100 is also more stable. Secondly, during interventional delivery and recovery, the first connecting part is forced to change its position. Due to the correlation between the radial dimension X1 and the axial dimension X2 when deformation occurs, the overall deformation state is gradually changed and controllable, which is easy to position and recover during interventional delivery. The first connecting member 210 only acts on the proximal end of the one-way valve device, and transmits the force to the distal end 222 of the support body 220 through the skeleton of the mesh cage structure. During recovery, on the one hand, the interventional delivery system pulls the proximal end 221 through the first connecting member 210, so that the axial dimension X2 of the mesh cage structure increases; on the other hand, the interventional delivery system acts on the side wall of the mesh cage structure, so that the radial dimension X1 of the mesh cage structure decreases. The axial dimension X2 and the radial dimension X1 are negatively correlated, which facilitates the interventional delivery system to control the overall shape of the mesh cage structure, and reduces the secondary damage to the airway 100 when the one-way valve device is removed.

[0067] To reveal the structural features of the exhaust slot 232, see Figure 1 and Figure 2 In the circumferential direction of the support body 220, the free edge 231 is provided with an exhaust groove 232 between any two adjacent support rods 223. There are multiple exhaust grooves 232, and the multiple exhaust grooves 232 are symmetrical in space as a whole. Further, the number of the exhaust grooves 232 is half of the number of the support rods 223 or the same as the number of the support rods 223.

[0068] To further reveal the structural features of the support body 220, see Figure 1 The support body 220 includes a plurality of support rods 223, one end of all the support rods 223 converges to the first connecting member 210, and the other end converges to the second connecting member, and the anchor member 400 is fixed to the second connecting member.

[0069] In this embodiment, the support rod 223 is used to prop up the diaphragm 230. The support body 220 as a whole has an axis in space and is axially symmetrical. The first connecting member 210 and the second connecting member are basically located at the axis position, and the second connecting member is located at the distal end 222 of the support body 220. The rod body curve of each support rod is smooth and has no obvious turning point. The number of support rods 223 is 4 to 8. For example, the number of support rods 223 is 6, and the corresponding number of exhaust grooves 232 is 3 or 6. The figure only shows that the number of exhaust grooves 232 is 3. The support rod 223 ensures the overall shape of the support body 220 and the close fit between the diaphragm 230 and the inner wall of the airway 100. In terms of material, the support rod is an elastic memory metal material.

[0070] Furthermore, all support rods 223 and the first connecting member 210 are fixed in a separate or integrated structure, and the adapting structure is a hook, a connecting hole, or an enlarged head. Figure 1The adapting structure on the first connecting member 210 shown in the figure adopts a retrieving hook 211, and the retrieving hook 211 can be formed by cutting a notch, for example. The interventional delivery system includes a traction member 110, and the distal end of the traction member has a retrieving pull ring 111, and the retrieving pull ring 111 acts on the retrieving hook 211 to realize the retraction of the one-way valve device by the interventional delivery system.

[0071] To further disclose the structural features of the anchor 400, see Figure 3a The anchoring member 400 includes a plurality of anchor rods 410 distributed radially, one end of each anchor rod 410 is fixed relative to the second connecting member, and the other end extends outward in the radial direction of the support body 220 and has a forked multi-strand anchor barb at the end.

[0072] The center of the radial distribution of the anchor 400 is one end of the anchor rod 410 fixed relatively to the second connecting member, and the forked multiple anchor spikes act on the inner wall of the airway 100 to achieve the positioning of the anchor 400. For example, any anchor rod 410 has a main anchor spike 411 and an auxiliary anchor spike 412. The main anchor spike 411 penetrates the inner wall of the airway 100 perpendicular to the axis of the support body 220 for overall positioning; the auxiliary anchor spike 412 presses against the inner wall of the airway 100 to prevent over-penetration and rollover. Specifically, the extension direction of the main anchor spike 411 is perpendicular to a section of the inner wall of the airway 100 where the support body 220 is located; the extension direction of the auxiliary anchor spike 412 is perpendicular to the main anchor spike 411.

[0073] To achieve the fixation of the anchor 400 and the support body 220, see Figure 3a One end of each anchor rod 410 is fixed to the third connecting member, and the third connecting member and the second connecting member are an integral structure or are nested and fixed. For example, the third connecting member uses an inner connecting ring 413, and the second connecting member uses an outer connecting ring 250, and the inner connecting ring 413 is nested and fixed to the outer connecting ring 250, or is welded and fixed to the outer connecting ring 250.

[0074] In order to minimize the damage of the anchor 400 to the airway 100, in one embodiment, see Figure 4The anchor 400 includes a plurality of anchor rods 420 distributed radially, each anchor rod extending radially outwardly from the support body 220 and having an action surface 421 matched with the inner wall of the airway 100, and the action surface 421 has a protruding friction-increasing component. The anchor rods 420 as a whole have an axis in space and are axially symmetrical, and the number is 4 to 8, for example, 6. The action surface 421 matches with the inner wall of the airway 100, which means that the action surface 421 keeps in contact with the inner wall of the airway 100. The friction-increasing component is fixedly arranged on the action surface 421, and radially protrudes outward to achieve friction fixation between the action surface 421 and the airway 100. Compared with the anchor thorn fixation method, this embodiment avoids damage to the airway 100 and reduces the possibility of inflammation of the airway 100 while ensuring the fixing effect and reducing the risk of rollover. The friction-increasing component can be, for example, a plurality of protrusions 422 arranged in sequence, each protrusion 422 is spherical crown-shaped and as protruding as possible to facilitate positioning. The arrangement may be, for example, a linear arrangement, a triangular arrangement or an array arrangement.

[0075] To enhance the stability of the anchor 400, in one embodiment, see Figure 4 As shown in the figure, a part of each anchor rod is a connecting arm 423, one end of which is fixedly connected to the outer connecting ring 250, and the other end is fixedly connected to the reverse side of the action surface 421 (relative to the reverse side of the action surface 421 contacting the inner wall of the airway 100), so that each anchor rod is curled into a closed loop structure, which improves stability and further ensures the effect of the friction-increasing component.

[0076] In order to enhance the flexibility of the one-way valve device, in one embodiment, the support body 220 and the anchor 400 can be deformed or flexibly connected. For example, the outer connecting ring 250 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 220 to form an angle with the axis of the anchor 400, and the overall posture is adaptive, so that it is applicable to a wider range of airways 100. Specifically, since the actual situation of the airway 100 is relatively complex and there are many bends, the area that can accommodate the one-way valve is relatively short. When the length of the one-way valve is long, the blocking effect in the curved airway 100 is not good. Compared with the relatively fixed connection between the anchor 400 and the support body 220, this embodiment can adapt to the complex airway 100 structure and achieve better blocking.

[0077] To disclose the interventional delivery and retrieval process of the one-way valve device, in one embodiment, see Figure 1 , Figure 5 ,and Figure 6 The one-way flap device has a compressed state for interventional delivery and a released state for operation, wherein Figure 5The semi-compressed state shown means that the support body 220 is in a compressed state and the anchor 400 is in a released state. Compared with the released state, the cage structure is radially contracted in the compressed state, and the distal end 222 and the proximal end 221 of the support body 220 are further away from each other.

[0078] In this embodiment, the opening angle of the recovery hook 211 is inclined toward the distal end 222 of the support body 220. During recovery or interventional delivery, the recovery sleeve 130 and the recovery pull ring 111 are inserted into the airway 100, and the recovery pull ring 111 is engaged with the recovery hook 211. The recovery hook 211 can be formed by cutting a notch, for example, to facilitate pulling the recovery hook 211 to move. Further, when the recovery pull ring 111 is engaged with the recovery hook 211, the interventional delivery system also includes a support tube 120 that fixes the two relatively. The support tube 120 is movably sleeved outside the traction member 110, and the recovery pull ring 111 extends out of the distal end of the support tube 120. The distal end of the support tube 120 is provided with a fixing groove 121, which is engaged with the recovery pull ring 111 through the fixing groove 121 and abuts against the first connecting member 210 in the distal direction. The support tube 120 can maintain a stable connection between the recovery pull ring 111 and the first connecting member 210 on the one hand, and can also provide necessary axial driving force.

[0079] The recovery sleeve 130 is smaller than the radial dimensions of the support body 220 and the anchor 400 in the released state. In this embodiment, the interventional delivery and recovery of the one-way valve device are achieved through the relative movement of the recovery sleeve 130 and the recovery pull ring 111. Specifically:

[0080] During interventional delivery, the anchor 400 is pushed out by the interventional delivery system through the recovery hook 211, restored to a released state and fixed on the inner wall of the airway 100; then the support body 220 is pushed out by the interventional delivery system through the recovery hook 211, restored to a released state, and together with the diaphragm 230 forms a blockade of the airway 100, and then the recovery pull ring 111 is withdrawn to complete the release.

[0081] During the recovery, the proximal end 221 of the support body 220 in the axial direction moves toward the human oral cavity under the action of the recovery hook 211, or the recovery sleeve 130 moves away from the human oral cavity under the action of the recovery hook 211. In this process, the support body 220 is deformed and contracted in the radial direction by the action of the recovery sleeve 130, and the relative distance between the proximal end 221 and the distal end 222 of the support body 220 gradually increases until the support body 220 is completely received in the recovery sleeve 130; then the anchor 400 moves toward the human oral cavity or the recovery sleeve 130 continues to move away from the human oral cavity, and the anchor 400 is deformed and concave in the radial direction by the force to detach from the airway 100, completing the recovery.

[0082] The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0083] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims

1. A 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 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 one-way flap device according to claim 1, characterized in that: The one-way flap device has a distal side and a proximal side opposite to each other, and the support body is a deformable mesh cage structure as a whole, and the mesh cage structure converges in shape at the distal end and the proximal end; The one-way flap device also includes: An anchor, fixed to the distal end of the support body; The first connecting member is fixed to the proximal end of the support body, and the first connecting member has an adapting structure for cooperating with the interventional delivery system.

3. The one-way flap device according to claim 2, characterized in that: The diaphragm is coated on a portion of the support body close to the distal end, and the free edge is located at the periphery of the support body and adjacent to a region where the outer diameter of the support body is the largest.

4. The one-way flap device according to claim 3, characterized in that: The support body comprises a plurality of support rods, one end of all the support rods converges to the first connecting member, and the other end converges to the second connecting member, and the anchor is fixed to the second connecting member; 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.

5. The one-way flap device according to any one of claims 2 to 4, characterized in that: The one-way valve device has a compressed state for interventional delivery and a released state during operation. Relative to the released state, the cage structure is radially contracted in the compressed state, and the distal end and the proximal end of the support body are further away from each other.

6. The one-way flap device according to claim 4, characterized in that: In the circumferential direction of the support body, the free edge is provided with an exhaust groove at a position between any two adjacent support rods.

7. The one-way valve device according to any one of claims 1 to 4, characterized in that: The exhaust groove extends along the generatrix direction of the support body; In the axial direction of the support body, the length of the exhaust groove is 25% to 65% of the length of the support body.

8. The one-way valve device according to any one of claims 1 to 4, 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.

9. The one-way valve device according to any one of claims 1 to 4, characterized in that: The fixing positions of the floating sheet and the diaphragm are located at the distal end side of the corresponding exhaust groove.

10. The one-way flap device according to claim 9, characterized in that: The floating sheet is aligned with the proximal edges of both the diaphragm.

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