Retractable one-way valve device

Abstract

The present application relates to a recyclable one-way valve device, which has a relative distal side and a proximal side, and includes: a support body, which is a deformable mesh cage structure as a whole, and the mesh cage structure converges in shape at the distal and proximal ends; a diaphragm, which covers the support body and is used to control the degree of opening of the airway; an anchor, which is fixed to the distal end of the support body; a first connector, which is fixed to the proximal end of the support body, and the first connector has an adapter structure for cooperating with an interventional delivery system. The present application makes the support force on the inner wall of the airway more stable through the mesh cage structure design of the support body, and the overall shape changes gradually and controllably when subjected to force, which facilitates the positioning and recovery of interventional delivery; the contact surface between the mesh cage structure and the inner wall of the airway is in elastic contact, which reduces the possibility of the support body causing damage to the inner wall of the airway.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a recyclable 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 a recyclable one-way valve device to address the above technical problems.

[0005] The recyclable one-way flap device of the present application has opposite distal and proximal sides, and includes: a support body, which is generally a deformable mesh cage structure, wherein the mesh cage structure converges in shape at the distal and proximal ends;

[0006] a diaphragm covering the support body and used to control the degree of opening of the airway;

[0007] an anchoring member fixed to the distal end of the support body;

[0008] 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.

[0009] 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; the contact surface between the mesh cage structure and the inner wall of the airway is elastic, reducing the possibility of the support body causing damage to the inner wall of the airway.

[0010] 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.

[0011] Optionally, the diaphragm is covered on the portion of the support body close to the distal side, and the diaphragm has a free edge relative to the support body that is movable to control the degree of airway opening. The free edge is located at the periphery of the support body and is located adjacent to the area with the largest outer diameter of the support body.

[0012] The diaphragm and the free edge allow 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.

[0013] Optionally, the support body includes 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 anchoring member is fixed to the second connecting member.

[0014] Ensure the overall shape of the support body and the close fit between the diaphragm and the inner wall of the airway.

[0015] The provision of the two connecting pieces facilitates the connection with the conveying system or auxiliary components, and also provides a hardware basis for adapting to different release methods.

[0016] 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.

[0017] The adapting structure realizes the mutual limitation between the interventional delivery systems, and can be released from each other when needed to realize the delivery, release or recovery of the one-way valve device.

[0018] Optionally, the anchoring member includes a plurality of radially distributed anchor rods, one end of each anchor rod is fixed relative to the second connecting member, and the other end extends outward in the radial direction of the support body and has a forked multi-strand anchor barb at the end.

[0019] The multiple anchor spikes act on the inner wall of the airway to achieve the positioning of the anchor.

[0020] Optionally, one end of each anchor rod is converged and fixed to a third connecting member, and the third connecting member and the second connecting member are an integral structure or are nested and fixed.

[0021] The third connecting member realizes relative fixation of the anchoring member and the supporting body through a relatively fixed relationship with the second connecting member. Different connection methods can be selected according to process or assembly requirements.

[0022] Optionally, the anchoring member includes a plurality of anchor rods distributed radially, each anchor rod extending outward in the radial direction of the support body and having an active surface that cooperates with the inner wall of the airway, and the active surface has an outwardly protruding friction-increasing component.

[0023] The friction-increasing component reduces the damage of the anchoring component to the airway as much as possible while ensuring the anchoring effect.

[0024] Optionally, each anchor rod is curled into a closed loop structure.

[0025] The closed-loop structure improves the stability of the anchor, reduces isolated branches or spikes to a certain extent, and further improves safety.

[0026] Optionally, the support body and the anchoring member are deformable or flexibly connected.

[0027] The flexibility of the retrievable one-way valve device is enhanced to adapt to different physiological environments.

[0028] 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 and proximal ends of the support body are further away from each other.

[0029] It can avoid compression and radial stacking into a multi-layer structure, reduce the overall outer diameter, and improve compliance during interventional delivery.

[0030] Optionally, in the circumferential direction of the support body, an exhaust groove is provided on the free edge between any two adjacent support rods.

[0031] A plurality of exhaust slots are provided in the circumferential direction to avoid or reduce the circumferential dead angle area.

[0032] Optionally, the exhaust groove extends along the generatrix direction of the support body;

[0033] 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.

[0034] The appropriate length of the exhaust groove can ensure the sensitivity of exhaust and reduce the material or strength requirements of the floating sheet.

[0035] Optionally, the exhaust slot is a slit extending in a straight line or gradually narrowing from the proximal side to the distal side.

[0036] Compared with slit extension, gradual narrowing can obtain a larger avoidance gap, which is more conducive to the discharge of secretions.

[0037] Optionally, the fixed position of the floating sheet and the diaphragm is located at the distal end side of the corresponding exhaust groove.

[0038] This allows the floating piece to have greater freedom when swinging open.

[0039] Optionally, the proximal edges of the floating sheet and the diaphragm are aligned.

[0040] The alignment of the proximal edges of the two can prevent the floating piece from being too short to completely close the exhaust slot, or from affecting the air tightness due to the floating piece being too long and sagging.

[0041] 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

[0042] Figure 1a Schematic diagram of the three-dimensional structure of a recyclable one-way valve device in one embodiment of the present application;

[0043] Figure 1b to Figure 1d for Figure 1a Schematic diagrams of different angles of the one-way valve device after omitting the diaphragm shown in FIG;

[0044] Figure 1e Schematic diagram of the three-dimensional structure of a recyclable one-way valve device in one embodiment of the present application;

[0045] Figure 1f for Figure 1e Schematic diagram of the cooperation relationship between the diaphragm and the floating plate in the one-way valve device shown in;

[0046] Figure 2 Schematic diagram of the three-dimensional structure of a recyclable one-way valve device in one embodiment of the present application.

[0047] Figure 3 This is a schematic structural diagram of a recyclable one-way valve device in a semi-compressed state according to an embodiment of the present application;

[0048] Figure 4 This is a schematic structural diagram of a recyclable one-way valve device in a compressed state according to an embodiment of the present application;

[0049] The reference numerals in the figures are described as follows:

[0050] 100, airway; 110, traction member; 111, recovery pull ring; 120, support tube; 121, fixing groove; 130, recovery sleeve;

[0051] 200, one-way flap device; 210, first connecting member; 211, recovery hook;

[0052] 220, support body; 221, proximal end; 222, distal end; 223, support rod;

[0053] 230, diaphragm; 231, free edge; 232, vent groove; 233, point;

[0054] 240, floating piece; 241, fixed end; 242, movable end;

[0055] 250, external connecting ring;

[0056] 400, anchoring member; 410, anchor rod; 411, main anchor spike; 412, auxiliary anchor spike; 413, inner connecting ring;

[0057] 420, anchor rod; 421, working surface; 422, protrusion; 423, connecting arm;

[0058] X1, radial dimension; X2, axial dimension. DETAILED DESCRIPTION

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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 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 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. 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 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, which is not easy to recover.

[0064] See also Figure 1a to Figure 1d One embodiment of the present application provides a recyclable one-way valve device 200, which has a relative distal side and a proximal side. It includes a support body 220, a diaphragm 230, an anchor 400 and a first connector 210. 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 diaphragm 230 covers the support body 220 and is used to control the degree of opening of the airway 100; the anchor 400 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 adaptor structure for cooperating with an interventional delivery system.

[0065] The proximal end or proximal side mentioned in each embodiment of the present application refers to the end or side that is relatively close to the human oral cavity during intervention, and the distal end or distal side refers to the end or side that is relatively far away from the human oral cavity during intervention. Unless otherwise specified, the structural features of the support body 220, the diaphragm 230 and the anchor 400 are assumed to be in a released state. The released state is also called the predetermined state. In this state, the overall posture of the recyclable one-way valve device will change when it is subjected to force. The support body 220 is deformable as a whole, which means that it can be compressed and accommodated in the intervention delivery system during intervention delivery or recovery. Specifically, the axial dimension X2 and the radial dimension X1 of the cage structure have a negative correlation in the changing trend. For example, in the predetermined state, it begins to deform under the radial inward force. During the deformation process, the axial dimension X2 increases, while the radial dimension X1 decreases at the same time. The diaphragm 230 realizes the function of one-way ventilation by controlling the degree of opening of the airway 100. The first connector 210 cooperates with the interventional delivery system so that, during interventional delivery and retrieval, the interventional delivery system acts on the first connector 210 to deliver the retrievable one-way valve device to a predetermined position and to retract it from that position. In other words, the adapting structure is used to achieve a detachable connection and allows the interventional delivery system to push and retract the retrievable one-way valve device via the first connector 210.

[0066] The support body 220 in this embodiment has a cage structure as a whole and its shape converges at the distal end 222 and the proximal end 221 , so the overall shape is roughly spindle-shaped.

[0067] The retrievable one-way valve device in this embodiment has the following advantages: First, the overall structure is more stable, and the support force on the inner wall of the airway 100 is also more stable. Second, during interventional delivery and retrieval, the first connecting portion is subjected to force and changes position. Due to the correlation between the radial dimension X1 and the axial dimension X2 during deformation, the overall deformation state is gradual and controllable, facilitating positioning and retrieval during interventional delivery. The first connecting member 210 acts only on the proximal end of the retrievable one-way valve device, transmitting the force to the distal end 222 of the support body 220 through the cage structure's skeleton. During retrieval, the interventional delivery system pulls on the proximal end 221 via the first connecting member 210, increasing the axial dimension X2 of the cage structure; secondly, the interventional delivery system acts on the sidewalls of the cage structure, reducing the radial dimension X1 of the cage structure. The negative correlation between the axial dimension X2 and the radial dimension X1 facilitates the interventional delivery system's control of the overall shape of the cage structure, minimizing secondary damage to the airway 100 during removal of the retrievable one-way valve device.

[0068] To further illustrate the mechanism of action of the retrievable one-way valve device, in one embodiment, see Figure 1aThe diaphragm 230 is covered on the distal end of the support body 220 . The diaphragm 230 has a free edge 231 that can be flexibly matched with the support body 220 to control the degree of opening of the airway 100 . The free edge 231 is located at the periphery of the support body 220 .

[0069] The diaphragm 230 in this embodiment is made of a soft material. When the recyclable one-way valve device reaches a predetermined position within the airway 100, during inspiration, gas flows from the proximal end 221 to the distal end 222, and the diaphragm 230 is subjected to radially outward force, causing the free edge 231 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 222 to the proximal end 221, and internal gas and secretions cause the free edge 231 to be subjected to radially inward force and deform, forming a gap between the diaphragm 230 and the inner wall of the airway 100. Through the above structural design, the recyclable one-way valve device can stably achieve one-way ventilation in the affected area after being implanted in the lung, thereby reducing lung volume, inhibiting lung hyperinflation, and improving respiratory function.

[0070] To maximize the blocking effect on the airway 100, the free edge 231 is located adjacent to the area with the largest outer diameter of the support body 220. This area of ​​the support body 220 with the largest outer diameter best fits the airway 100, thus achieving the greatest effect. In this embodiment, the diaphragm 230 utilizes a multi-layered film structure to better facilitate the discharge of internal gas and secretions.

[0071] To further illustrate the structural features of the support body 220, see Figure 1a 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.

[0072] In this embodiment, support rods 223 are used to prop up the diaphragm 230. The support body 220 as a whole is spatially symmetrical with an axis. The first connector 210 and the second connector are substantially located along the axis, with the second connector located at the distal end 222 of the support body 220. Each support rod has a smooth curve without distinct inflections. There are four to eight support rods 223, for example, six. The support rods are made of elastic memory metal.

[0073] Furthermore, there is a relative positional relationship between the diaphragm 230 and the support rods 223. Along the axial direction of the support body 220, the free edge 231 is located in the middle area of ​​the support body 220, and the free edge 231 is continuously distributed or discontinuously distributed between the support rods 223 along the circumference 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. The circumferential discontinuous distribution of the free edge 231 means that the area where the free edge 231 contacts the support rods 223 is fixed. It can be understood that at this time, when the free edge 231 is in the inhalation or exhalation state, the deformation of the free edge 231 in the middle position between any two support rods 223 is the largest, and the deformation at other positions decreases as the distance from the adjacent support rod 223 decreases; the circumferential continuous distribution of the free edge 231 means that the area where the free edge 231 contacts the support rods 223 is allowed to move. Compared to the circumferentially discontinuous distribution of the free edge 231, the circumferentially continuous distribution of the free edge 231 allows for more flexible deformation and movement. To achieve a more secure fixation of the diaphragm 230 relative to the support body 220, the free edge 231 of the diaphragm 230 further extends over the area of ​​the support body 220 with the largest outer diameter.

[0074] Furthermore, all support rods 223 and the first connecting member 210 are fixed in a split or integrated structure, and the adaptable structure is a hook, a connecting hole, or an enlarged head. For example, Figure 1a The adapting structure on the first connecting member 210 shown in the figure adopts a recovery hook 211. The recovery 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 recovery pull ring 111. The recovery pull ring 111 acts on the recovery hook 211 to realize the retraction of the retractable one-way valve device by the interventional delivery system.

[0075] To further illustrate the structural features of the anchor 400, see Figure 1a 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 radially outward in the support body 220 and has a forked multi-strand anchor barb at the end.

[0076] The center of the radial distribution of anchors 400 is one end of an anchor rod 410 fixed relative to the second connector. 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 220 and is used for overall positioning; the secondary anchor spike 412 abuts the inner wall of the airway 100 to prevent excessive penetration and rollover. Specifically, the primary anchor spike 411 extends perpendicular to the section of the inner wall of the airway 100 where the support body 220 is located; the secondary anchor spike 412 extends perpendicular to the primary anchor spike 411.

[0077] To achieve the fixation of the anchor 400 and the support 220, see Figure 1aOne end of each anchor rod 410 converges and is fixed to a third connecting member. The third connecting member and the second connecting member are integrally structured or nested. For example, the third connecting member is an inner connecting ring 413, and the second connecting member is an outer connecting ring 250. The inner connecting ring 413 is nested and fixed to the outer connecting ring 250, or is welded to the outer connecting ring 250.

[0078] See also Figure 1e and Figure 1f In one embodiment, the free edge 231 is provided with an exhaust groove 232, the proximal side of the exhaust groove 232 is open, and the diaphragm 230 is further 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.

[0079] Because the free edge 231 is provided with a venting groove 232, during inhalation, the venting groove 232 is closed by the floating sheet 240, which does not affect the diaphragm 230's ability to block the airway 100. During exhalation, the floating sheet 240 opens the venting groove 232, allowing the free edge 231 to deform radially inward without being affected by the circumferential traction of the free edge 231. This allows the free edge 231 to move more flexibly and deform more, creating a larger gap between the diaphragm 230 and the inner wall of the airway 100, further facilitating the discharge of secretions. It can be appreciated that because the venting groove 232 facilitates the discharge of internal gas or secretions, the diaphragm 230 in this embodiment can be thicker than conventional prior art devices.

[0080] The exhaust slot 232 extends along the generatrix of the support body 220. In the axial direction of the support body 220, the exhaust slot 232 has a length D1 that is 25% to 65% of the length of the support body 220 (i.e., the axial dimension X2), for example, 30%. Furthermore, the exhaust slot 232 is a linear slit or gradually narrows from the proximal end to the distal end.

[0081] The support body 220, as a whole, appears spatially as a rotating body with a generatrix and an axis. The axis roughly coincides with the line connecting the proximal end 221 and the distal end 222. A venting slot 232 is defined on the proximal side of the diaphragm 230 and extends toward the distal end of the diaphragm 230, reaching a length D1. The floating sheet 240 is strip-shaped and extends along the generatrix of the mesh structure. Along the length of the floating sheet 240, the area where the floating sheet 240 aligns with the venting slot 232 constitutes the working section. This working section gradually tapers toward the proximal end of the floating sheet 240. Furthermore, along the length of the floating sheet 240, the working section gradually tapers from its mid-section toward the proximal end of the floating sheet 240, further enhancing the sealing effect and opening and closing sensitivity.

[0082] To further illustrate the function and effect of the vent grooves 232, the floating plate 240 is fixed to the diaphragm 230 at the distal end of the corresponding vent grooves 232. Specifically, the floating plate 240 includes a fixed end 241 and a movable end 242, which are located at opposite ends in the longitudinal direction. The working section is the portion of the floating plate 240 adjacent to the fixed end 241. The floating plate 240 is entirely located radially inward of the diaphragm 230. The fixed end 241 is fixed relative to the diaphragm 230, while the movable end 242 engages and seals the diaphragm 230 during inhalation and moves away from the diaphragm 230 during exhalation, creating a clearance. The fixed end 241 can be secured to the inner side of the diaphragm 230, for example, by adhesive bonding. Furthermore, the proximal edges of the floating plate 240 and the diaphragm 230 are aligned, and the floating plate 240 does not extend beyond the proximal side of the diaphragm 230. The length of the floating piece 240 in the axial direction is greater than the length D1 of the exhaust groove 232 to ensure the stability of the fixing between the floating piece 240 and the diaphragm 230 .

[0083] In the axial direction of the support body, the distal end of the vent groove 232 is located in the central region of the diaphragm 230. Specifically, the length of the projection of the diaphragm 230 on the support body axis is D2, and the midpoint of the projection is point 233. The distal end of the vent groove 232 is close to the axial position of point 233, for example, the distance is less than or equal to 15% of D2.

[0084] Along the circumference of the support body 220, the free edge 231 defines an air vent 232 between any two adjacent support rods 223. Multiple air vents 232 are provided, and the plurality of air vents 232 are spatially symmetrical. Furthermore, the number of air vents 232 is half the number of support rods 223, or the same as the number of support rods 223.

[0085] In one embodiment, see Figure 2 The anchor 400 includes multiple radially distributed anchor rods 420. Each anchor rod extends radially outward from the support body 220 and has an active surface 421 that engages the inner wall of the airway 100. The active surface 421 includes a protruding friction-enhancing component. The anchor rods 420 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, ensuring that the active surface 421 maintains contact with the inner wall. 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 422 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.

[0086] In one embodiment, see Figure 2 Each anchor rod is curled into a closed loop structure. A portion 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 opposite side of the active surface 421 (the side opposite to the side where the active surface 421 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.

[0087] 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 relative to 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 sealing 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 structure of the airway 100 and achieve better sealing.

[0088] To disclose the interventional delivery and retrieval process of a retrievable one-way valve device, in one embodiment, see Figure 1a 、 Figure 3 ,and Figure 4 The one-way valve device has a compressed state for interventional delivery and a released state for operation, wherein Figure 3 The 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.

[0089] In this embodiment, the opening angle of the retrieval hook 211 is inclined toward the distal end 222 of the support body 220. During retrieval or interventional delivery, the retrieval sleeve 130 and the retrieval pull ring 111 are inserted into the airway 100, and the retrieval pull ring 111 engages with the retrieval hook 211 to facilitate pulling the retrieval hook 211 to move. Furthermore, when the retrieval pull ring 111 engages with the retrieval hook 211, the interventional delivery system also includes a support tube 120 that relatively fixes the two. The support tube 120 is movably sleeved on the outside of the traction member 110, and the retrieval 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 engages with the retrieval pull ring 111 through the fixing groove 121 and presses against the first connecting member 210 in the distal direction. On the one hand, the support tube 120 can maintain a stable connection between the retrieval pull ring 111 and the first connecting member 210, and on the other hand, it can also provide the necessary axial driving force.

[0090] The retrieval sleeve 130 is smaller than the radial dimensions of the support body 220 and the anchor 400 in the released state. This embodiment achieves interventional delivery and retrieval of the retrievable one-way valve device through the relative movement of the retrieval sleeve 130 and the retrieval pull ring 111. Specifically:

[0091] 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 blockage on the airway 100, and then the recovery pull ring 111 is withdrawn to complete the release.

[0092] During recovery, the proximal end 221 of the support body 220 moves toward the oral cavity of the human body under the action of the recovery hook 211, or the recovery sleeve 130 moves away from the oral cavity of the human body under the action of the recovery hook 211. During this process, the support body 220 deforms and contracts in the radial direction due to the force 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 oral cavity of the human body or the recovery sleeve 130 continues to move away from the oral cavity of the human body, and the anchor 400 is deformed inward in the radial direction due to the force and detached from the airway 100, completing the recovery.

[0093] 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.

[0094] 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. A retrievable one-way flap device having opposed distal and proximal sides, characterized in that: include: The support body is a deformable mesh cage structure as a whole, and the mesh cage structure converges in shape at its distal end and proximal end; a diaphragm covering the support body for controlling the degree of airway patency, the diaphragm having a free edge that movably cooperates with the support body to control the degree of airway patency, the free edge being located at the periphery of the support body, the diaphragm covering a portion of the support body near the distal end, the free edge being located adjacent to the region with the largest outer diameter of the support body, or the free edge passing over the region with the largest outer diameter of the support body toward the proximal end of the support body; an anchoring member fixed to the distal end of the support body; a first connecting member fixed to the proximal end of the support body, the first connecting member having an adapting structure for cooperating with an interventional delivery system; The free edge is provided with an exhaust groove, the proximal side of the exhaust groove is open, the exhaust groove is provided on the proximal side of the diaphragm and extends toward the distal side of the diaphragm, and the diaphragm is also connected to a floating plate arranged near the exhaust groove, and the exhaust groove can be closed or opened during the movement of the floating plate.

2. The recyclable one-way valve device according to claim 1, characterized in that: The area where the floating sheet matches the exhaust groove is a working section, and the working section gradually becomes thinner in the area adjacent to the proximal end of the floating sheet.

3. The recyclable one-way valve device according to claim 1, characterized in that: The entire floating plate is located radially inward of the diaphragm.

4. The recyclable one-way valve device according to claim 1, characterized in that: The proximal end side of the exhaust groove is open, and the exhaust groove is a slit extending in a straight line or gradually narrowing from the proximal end side to the distal end side.

5. The recyclable one-way valve device according to claim 1, characterized in that: The support body includes 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.

6. The recyclable one-way valve device according to claim 5, characterized in that: 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.

7. The recyclable one-way valve device according to claim 5, characterized in that: The anchoring member comprises a plurality of anchor rods distributed radially, one end of each anchor rod being fixed relative to the second connecting member, and the other end extending outward in the radial direction of the support body and having a forked plurality of anchor spikes at the end.

8. The retrievable one-way valve device according to claim 7, characterized in that: One end of each anchor rod is converged and fixed to a third connecting member, and the third connecting member and the second connecting member are an integral structure or are nested and fixed.

9. The recyclable one-way valve device according to claim 1, characterized in that: The anchoring member includes a plurality of anchor rods distributed radially, each anchor rod extending outward in the radial direction of the support body and having an action surface that cooperates with the inner wall of the airway, the action surface having an outwardly convex friction-increasing component, and each anchor rod is curled into a closed loop structure.

10. The recyclable one-way valve device according to any one of claims 1 to 9, characterized in that: The support body and the anchoring member are deformable or flexibly connected; 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.

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