CN114224417A

CN114224417A - Recoverable one-way valve device

Info

Publication number: CN114224417A
Application number: CN202111488953.3A
Authority: CN
Inventors: 王茂强; 关玉; 徐宏
Original assignee: Hangzhou Kunbo Biotechnology Co Ltd
Current assignee: Hangzhou Kunbo Biotechnology Co Ltd
Priority date: 2021-12-07
Filing date: 2021-12-07
Publication date: 2022-03-25

Abstract

The present application relates to a retrievable one-way valve device having opposite distal and proximal sides, comprising: a support body integrally being a deformable mesh cage structure that converges in shape at its distal and proximal ends; a diaphragm covering the support body for controlling the opening degree of the airway; an anchor secured to a distal end of the support body; and the first connecting piece is fixed at the proximal end of the support body and is provided with an adaptive structure matched with the interventional conveying system. The supporting force to the inner wall of the air passage is more stable through the mesh cage structural design of the supporting body, the whole form is gradually changed and controllable when being stressed, and the positioning and the recovery of the intervention conveying are easy; the contact surface of the cylinder mould structure and the inner wall of the air passage is in elastic contact, so that the possibility of damage of the support body to the inner wall of the air passage is reduced.

Description

Recoverable one-way valve device

Technical Field

The application relates to the field of medical equipment, in particular to a recyclable one-way valve device.

Background

Chronic Obstructive Pulmonary Disease (COPD) is an incurable disease with high morbidity and the third highest morbidity in the world. Common treatment modalities include drug therapy and surgical lung reduction surgery (LVRS). The international initiative for chronic obstructive pulmonary disease (Gold guideline) of 2017 updated recommended endoscopic lung volume-reduction (ELVR) to be selectively applicable to severe COPD patients, to be safer than LVRS, and to be particularly applicable to people who are not suitable for LVRS.

The one-way valve flap implantation is the most reported method of the ELVR in recent years, and is used for implanting the one-way valve flap into a severely diseased lung lobe bronchial airway (hereinafter, the lung lobe is simply referred to as an airway) through the ELVR to block air from entering a treated lung lobe, but allow air in the lung lobe to be blocked to be exhaled, promote emphysema tissue collapse, and is the preferred ELVR scheme for severe COPD patients without obvious side ventilation. The one-way valve flap implantation is widely accepted due to high price and poor effect of drug therapy, high risk of lung volume reduction surgery, great harm to human body and high death rate. The existing one-way valve flaps mainly include duckbill-type bronchial flaps ebv (pulmonx) and umbrella-shaped endobronchial flaps ibv (olympus). Compared with the traditional operation and drug treatment, the one-way valve has lower cost, and the performed operation has small damage to the human body, simple operation, small wound and low risk. However, the airway environment of the bronchus is complex, so that the two existing one-way valve products have poor effects under different airway structures.

Disclosure of Invention

In view of the above, it is desirable to provide a recoverable one-way valve device.

The present retrievable one-way valve device, having opposite distal and proximal sides, comprises: a support body integrally being a deformable mesh cage structure that converges in shape at its distal and proximal ends;

a diaphragm covering the support body for controlling the opening degree of the airway;

an anchor secured to a distal end of the support body;

and the first connecting piece is fixed at the proximal end of the support body and is provided with an adaptive structure matched with the interventional conveying system.

The structural design of the net cage of the supporting body ensures that the supporting force on the inner wall of the air passage is more stable, the integral form is gradually changed and controllable when being stressed, and the positioning and the recovery of the interventional conveying are easy; the contact surface of the cylinder mould structure and the inner wall of the air passage is in elastic contact, so that the possibility of damage of the support body to the inner wall of the air passage is reduced.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the membrane is coated on a portion of the support body near the distal side, and the membrane has a free edge movably fitted to the support body to control the opening degree of the airway, and the free edge is located on the periphery of the support body and is located adjacent to the area with the largest outer diameter of the support body.

The diaphragm and the free edge enable internal gas and secretion to be discharged from a gap between the diaphragm and the inner wall of the airway, so that the one-way ventilation function is realized.

Optionally, the support body includes a plurality of support rods, one end of each support rod is assembled to the first connecting member, the other end of each support rod is assembled to the second connecting member, and the anchoring member is fixed to the second connecting member.

The integral shape of the support body and the close fit between the diaphragm and the inner wall of the air passage are ensured.

The arrangement of the two connecting pieces is convenient for being matched and connected with a conveying system or an auxiliary component, and provides a hardware basis for adapting to different releasing modes.

Optionally, all the support rods and the first connecting piece are of a split fixing or integrated structure, and the adaptive structure is a hook, a connecting hole or an expansion head.

The adaptation structure realizes limiting among the interventional delivery systems, and can be disengaged from each other when needed, so that the one-way valve device is delivered, released or recovered.

Optionally, the anchor comprises a plurality of radially distributed anchor rods, one end of each anchor rod is fixed opposite to the second connecting member, and the other end of each anchor rod extends radially outwards from the support body and is provided with a plurality of bifurcate anchor stabs at the tail end.

The multiple anchors penetrate the inner wall of the airway to effect positioning of the anchors.

Optionally, one end of each anchor rod is converged and fixed to a third connecting piece, and the third connecting piece and the second connecting piece are in an integral structure or are fixed in a nested manner.

The third connecting piece realizes the relative fixation of the anchor and the support body through the relative fixed relation with the second connecting piece, and different connecting modes can be selected according to the process or assembly requirements.

Optionally, the anchor comprises a plurality of radially distributed anchor rods, each anchor rod extends radially outward from the support body and has an active surface matched with the inner wall of the air passage, and the active surface is provided with a convex friction increasing part.

The friction increasing part reduces the damage of the anchoring piece to the air channel as much as possible, and simultaneously ensures the anchoring effect.

Optionally, each anchor is crimped to a closed loop configuration.

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

Optionally, the support body and the anchor are deformable or flexibly connected.

The flexibility of the recoverable one-way valve device is enhanced, and the device is suitable for different physiological environments.

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

Can avoid compressing and radially stacking to multilayer structure, reduce whole external diameter, improve the compliance when intervene and carry.

Optionally, an exhaust groove is formed in the position, between any two adjacent support rods, of the free edge in the circumferential direction of the support body.

The plurality of exhaust grooves are arranged in the circumferential direction, so that a dead angle area in the circumferential direction can be avoided or reduced.

Optionally, the exhaust duct extends along a generatrix direction of the support body;

the length of the exhaust groove is 25-65% of the support body in the axial direction of the support body.

The proper length of the exhaust groove can ensure the exhaust sensitivity and can also reduce the requirements on the material or the strength of the floating sheet.

Optionally, the exhaust slot is a slit extending linearly or narrowing gradually from the proximal side to the distal side.

The gradual narrowing can obtain larger avoiding gap compared with the slit extension, and is more beneficial to discharge of secretion.

Optionally, the fixing position of the floating tab to the diaphragm is at a distal side of the respective vent slot.

The floating sheet can be swung to be opened to obtain larger freedom degree.

Optionally, the floating tab is aligned with the proximal edges of both of the diaphragms.

The alignment of the near end edges of the two can avoid the air tightness being influenced because the floating piece is too short to completely close the exhaust groove or because the floating piece is too long to droop.

The recoverable one-way valve device of this application has improved the air flue control effect through structural improvement, has also compromise the security.

Drawings

FIG. 1a is a schematic perspective view of a recoverable one-way valve assembly according to an embodiment of the present application;

FIGS. 1 b-1 d are schematic views of the one-way valve device shown in FIG. 1a at different angles with the diaphragm omitted;

FIG. 1e is a schematic perspective view of a recoverable one-way valve assembly according to an embodiment of the present application;

FIG. 1f is a schematic view of the engagement of the diaphragm and the floating piece in the one-way valve device shown in FIG. 1 e;

fig. 2 is a schematic perspective view of a recoverable one-way valve device according to an embodiment of the present application.

FIG. 3 is a schematic view of a semi-compressed state of a recoverable one-way valve assembly according to an embodiment of the present application;

FIG. 4 is a schematic view of a retractable one-way valve assembly according to an embodiment of the present disclosure in a compressed state;

the reference numerals in the figures are illustrated as follows:

100. an airway; 110. a traction member; 111. recovering the pull ring; 120. supporting a tube; 121. fixing grooves; 130. recovering the sleeve;

200. a one-way flap device; 210. a first connecting member; 211. the hook is recovered;

220. a support body; 221. a proximal end; 222. a distal end; 223. a support bar;

230. a diaphragm; 231. a free edge; 232. an exhaust groove; 233. point;

240. a floating piece; 241. a fixed end; 242. a movable end;

250. an outer connecting ring;

400. an anchor; 410. an anchor rod; 411. main anchor stabs; 412. auxiliary anchoring; 413. an inner connecting ring;

420. an anchor rod; 421. acting surface; 422. a protrusion; 423. a connecting arm;

x1, radial dimension; x2, axial dimension.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In this application, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implying any particular order or number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In this application, the terms "comprises" and "comprising," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a system, article, or apparatus that comprises a list of elements is not necessarily limited to those elements explicitly listed, but may include other elements not expressly listed or inherent to such system or apparatus.

The prior art duckbill type bronchial valve EBV is composed of a support net and two pieces of valves located in the middle of the support net. When placed in the airway, it achieves one-way ventilation by the movement of the two pieces of valve, blocking the gas from entering the lung lobes to be treated. The mode of realizing the one-way ventilation is as follows: both valves open during exhalation and close during inhalation. But the two valves are in the middle of the supporting net, thereby being not beneficial to the discharge of secretion from the bronchus. And the umbrella-shaped endobronchial valve IBV comprises an umbrella-shaped support frame covered with a layer of diaphragm and the diaphragm used for forming the blockage of the airway. The umbrella-shaped endobronchial valve IBV is of an open structure at two ends, so that the stability in the air passage needs to be improved. In order to facilitate the intervention and the recovery, a connecting part for recovery extends out of the middle of the umbrella-shaped support frame, and the axial length of the connecting part exceeds that of the umbrella-shaped support frame. The connecting part drives the whole umbrella-shaped endobronchial valve and is not easy to recover.

Referring to fig. 1 a-1 d, one embodiment of the present application provides a retrievable one-way valve device 200 having opposite distal and proximal sides. Including support 220, membrane 230, anchor 400, and first connector 210. Wherein the support body 220 is a deformable mesh cage structure as a whole, which converges in shape at the distal end 222 and the proximal end 221 thereof; the diaphragm 230 is attached to the support 220 for controlling the opening degree of the airway 100; anchor 400 is secured to distal end 222 of support body 220; a first connector 210 is secured to the proximal end 221 of the support body 220. the first connector 210 carries an adapter structure for mating with an interventional delivery system.

In the embodiments of the present application, the proximal end or the proximal side refers to an end or a side relatively close to the oral cavity of the human body during the intervention, and the distal end or the distal side refers to an end or a side relatively far away from the oral cavity of the human body during the intervention. The support 220, membrane 230, and anchor 400 are all described with the stated structural features as default in a released state, unless otherwise specified. The released state, or pre-set state, in which the overall attitude of the recoverable one-way flap arrangement changes when subjected to a force. The support 220 is deformable as a whole, and is capable of being compressed and stored in the interventional delivery system during interventional delivery or collection. In particular, the trends of the axial dimension X2 and the radial dimension X1 of the netpen structure are inversely related, for example, the netpen structure starts to deform by a radially inward force in a preset state, and the axial dimension X2 increases while the radial dimension X1 decreases. The diaphragm 230 functions as a one-way vent by controlling the degree of openness of the airway 100. The first connecting member 210 is coupled to the interventional delivery system, which means that the interventional delivery system acts on the first connecting member 210 to bring the recoverable one-way valve device to a predetermined position and withdraw it from the predetermined position during interventional delivery and recovery. That is, the adapter structure is used to enable detachable connection and for the interventional delivery system to push and retract the retrievable one-way flap device through the first connector 210.

The support 220 in this embodiment is generally in the form of a spindle due to its overall configuration, which is generally in the form of a netpen, and which itself converges in the shape of the distal end 222 and the proximal end 221.

The recoverable one-way flap device in this embodiment has the following effects: first, the overall structure is more stable, and the supporting force against the inner wall of the air path 100 is also more stable. Secondly, when intervene and carry and retrieve, first connecting portion atress change position for the state gradual change of whole deformation is controllable owing to the relevance of radial dimension X1 and axial dimension X2 when taking place deformation, easily intervene location and the recovery of carrying. The first link 210 acts only on the proximal end of the retrievable one-way flap device, transmitting force through the skeleton of the netpen structure to the distal end 222 of the support body 220. Upon retrieval, the interventional delivery system pulls on the proximal end 221 via the first link 210, on the one hand, causing the axial dimension X2 of the netpen structure to increase; on the other hand, the interventional delivery system acts on the side wall of the netpen structure, so that the radial dimension X1 of the netpen structure is reduced. And the axial dimension X2 and the radial dimension X1 are inversely related, so that the control of the interventional delivery system on the whole shape of the mesh cage structure is facilitated, and the secondary damage to the air passage 100 when the recyclable one-way valve device is taken out is reduced.

To further illustrate the mechanism of action of the retrievable one-way flap device, in one embodiment, referring to fig. 1a, the membrane 230 is coated on a portion of the support 220 near the distal side, the membrane 230 has a free edge 231 that is movably fitted with respect to the support 220 to control the opening degree of the airway 100, and the free edge 231 is located at the periphery of the support 220.

The diaphragm 230 in this embodiment is made of a soft material, and when the recoverable one-way valve device reaches a predetermined position in the airway 100: when the gas flows from the near end 221 to the far end 222 during inhalation, the diaphragm 230 is forced radially outwards, so that the free edge 231 is closer to the inner wall of the airway 100 to form a barrier, and the gas cannot enter continuously; when the gas flows from the distal end 222 to the proximal end 221 during exhalation, the inner gas and secretions deform the free edge 231 radially inwards, and the diaphragm 230 forms a gap with the inner wall of the airway 100. Through the structural design, the recoverable one-way valve device can stably realize one-way ventilation of a focus area after being implanted into the lung, so that the aims of reducing lung capacity and inhibiting over-expansion of the lung are fulfilled, and the respiratory function is improved.

In order to achieve the maximum sealing effect on the air passage 100, the free edge 231 is located adjacent to the area with the largest outer diameter of the support 220, and the area with the largest outer diameter of the support 220 is best fitted with the air passage 100, so that the maximum effect can be achieved. In this embodiment, the diaphragm 230 has a multi-layer thin film structure, so that the effect of discharging the internal gas and the secretion is better.

To further reveal the structural features of the supporting body 220, referring to fig. 1a, the supporting body 220 includes a plurality of supporting rods 223, one end of each supporting rod 223 is converged to the first connector 210, the other end is converged to the second connector, and the anchor 400 is fixed to the second connector.

In this embodiment, the support rods 223 are used to support the diaphragm 230. The support body 220 is generally axially and symmetrically axially oriented, the first connector 210 and the second connector being substantially axially oriented, the second connector being located at a distal end 222 of the support body 220. The shaft curves of the support rods are smooth and have no obvious turning, and the number of the support rods 223 is 4-8, for example, 6. From the material, the support rod is made of elastic memory metal material.

Further, the diaphragm 230 and the support rod 223 have a relative positional relationship. The free edge 231 is located at the central region of the support body 220 along the axial direction of the support body 220, and the free edge 231 is continuously or discontinuously distributed between the support bars 223 along the circumferential direction of the support body 220. The central region of the support body 220 refers to a region where the outer diameter of the support body 220 is the largest. The intermittent distribution of the free edge 231 in the circumferential direction means that the contact area of the free edge 231 and the support bar 223 is fixed. It can be understood that, at this time, in the inspiration or expiration state of the free edge 231, the deformation amount of the free edge 231 at the middle position of any two support bars 223 is the largest, and the deformation amount at other positions is reduced along with the reduction of the distance from the adjacent support bars 223; the continuous circumferential distribution of the free edge 231 means that the contact area of the free edge 231 with the support bar 223 allows movement. Compared with the mode that the free edges 231 are circumferentially discontinuously distributed, the deformation and movement of the free edges 231 in the circumferentially continuous distribution state are more flexible. To achieve a more secure fixation of the diaphragm 230 with respect to the support body 220, further, the free edge 231 of the diaphragm 230 passes over the area of the support body 220 where the outer diameter is the largest.

Further, all the support rods 223 and the first connecting member 210 are fixed in a split manner or are integrated, and the adaptive structure is a hook, a connecting hole or an expansion head. For example, the adaptive structure on the first connector 210 shown in fig. 1a employs a recovery hook 211, the recovery hook 211 can be, for example, a notch formed by cutting, the interventional delivery system comprises a traction member 110 having a recovery pull ring 111 at a distal end thereof, and the recovery pull ring 111 acts on the recovery hook 211 to enable the interventional delivery system to withdraw the recoverable one-way flap device.

To further illustrate the structural features of the anchor 400, referring to fig. 1a, the anchor 400 includes a plurality of radially extending anchor rods 410, each anchor rod 410 having one end fixed to the second connecting member and the other end extending radially outward from the support body 220 and terminating with a plurality of bifurcated barbs.

The center of the radial distribution of the anchor 400 is the end of the anchor rod 410 fixed opposite the second connector. For example, each anchor rod 410 is provided with a primary barb 411 and a secondary barb 412. The main anchor 411 is perpendicular to the axis of the support body 220 and penetrates into the inner wall of the air channel 100 for integral positioning; the secondary anchors 412 bear against the inner wall of the airway 100 to prevent rollover from occurring when the penetration is too deep. Specifically, the extension direction of the main anchor 411 is perpendicular to a section of the inner wall of the airway 100 where the support 220 is located; the secondary anchor 412 extends in a direction perpendicular to the primary anchor 411.

To fix the anchor 400 to the supporting body 220, referring to fig. 1a, one end of each anchor rod 410 is converged and fixed to a third connecting member, and the third connecting member and the second connecting member are integrally configured or fixed in a nesting manner. For example, the third connector uses the inner connection ring 413, the second connector uses the outer connection ring 250, and the inner connection ring 413 is fixed to the outer connection ring 250 in a nested manner or fixed to the outer connection ring 250 by welding.

Referring to fig. 1e and 1f, in one embodiment, the free edge 231 is provided with an air vent groove 232, the proximal side of the air vent groove 232 is open, the diaphragm 230 is further connected with a floating plate 240 arranged near the air vent groove 232, and the floating plate 240 can close or open the air vent groove 232 during the movement process.

Because the free edge 231 is provided with the exhaust groove 232: the air discharge groove 232 is sealed by the floating sheet 240 during air suction, so that the sealing effect of the diaphragm 230 on the air passage 100 is not influenced; the floating piece 240 opens the exhaust groove 232 during expiration, the deformation of the free edge 231 towards the radial inner side is not affected by the circumferential traction of the free edge 231, the movement of the free edge 231 is more sensitive, the deformation amount is larger, the gap between the diaphragm 230 and the inner wall of the air passage 100 is larger, and the discharge of secretion is more facilitated. It will be appreciated that the diaphragm 230 in this embodiment allows for a greater thickness than conventional prior art because the vent slots 232 allow for easier venting of internal gases or secretions.

The exhaust groove 232 extends along the generatrix direction of the support body 220; the length D1 of the exhaust groove 232 may be 25% to 65% of the length (i.e., the axial dimension X2) of the support 220 in the axial direction of the support 220, for example, 30%. Further, the vent groove 232 is a slit extending straight or narrowing from the proximal side to the distal side.

The support body 220 is spatially overall represented as a body of revolution with a generatrix and an axis which substantially coincides with the line connecting the proximal end 221 and the distal end 222, the vent groove 232 opening on the proximal side of the septum 230 and extending towards the distal side of the septum 230 until a length D1 is reached. The floating piece 240 is strip-shaped and extends along a bus of the cylinder mould structure, and along the length direction of the floating piece 240, the area where the floating piece 240 is matched with the exhaust groove 232 is a working section, and the working section is gradually thinned in the area adjacent to the proximal end side of the floating piece 240. Further, along the length of the floating piece 240, the working segment becomes thinner gradually from the central region to the proximal side of the floating piece 240. Further enhancing the plugging effect and the sensitivity of opening and closing.

To further reveal the manner and effect of the vent slots 232, the attachment location of the float plate 240 to the diaphragm 230 is on the distal side of the respective vent slot 232. Specifically, the floating piece 240 includes a fixed end 241 and a movable end 242, the fixed end 241 and the movable end 242 are located at two ends in the length direction, and the working section is the portion of the floating piece 240 adjacent to the fixed end 241. The floating piece 240 is integrally located on the radial inner side of the diaphragm 230, the fixed end 241 is fixed relative to the diaphragm 230, the movable end 242 is attached to and seals the diaphragm 230 along with the inspiration of a human body, and is far away from the diaphragm 230 along with the expiration of the human body, so that an avoidance gap is formed. The fixing means of the fixing end 241 may be, for example, adhesive bonded to the inner side of the diaphragm 230. Further, the floating tab 240 is aligned with the proximal edges of both of the diaphragms 230, the floating tab 240 not extending beyond the proximal side of the diaphragm 230. The length of the axially upper floating plate 240 is greater than the length D1 of the air discharge groove 232, so as to ensure the fixing stability of the floating plate 240 and the diaphragm 230.

The distal side of the vent slot 232 is located in the middle region of the diaphragm 230 in the axial direction of the support body. Specifically, the length of a projected line segment of the diaphragm 230 on the support axis is D2, and the midpoint of the projected line segment is point 233. The distal side of the vent slot 232 is close to the axial location of point 233, e.g., a distance equal to or less than 15% of D2.

An exhaust groove 232 is formed on the free edge 231 between any two adjacent support rods 223 along the circumference of the support body 220. The plurality of exhaust grooves 232 are provided, and the plurality of 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 bars 223 or the same as the support bars 223.

In one embodiment, referring to FIG. 2, anchor 400 comprises a plurality of radially extending anchors 420, each anchor extending radially outward from support body 220 and having an active surface 421 for engaging the inner wall of airway 100, the active surface 421 having a convex friction enhancing feature thereon. The anchor rods 420 have axes in space and are axisymmetric, and the number of the anchor rods is 4 to 8, for example, 6. The cooperation between the action surface 421 and the inner wall of the air passage 100 means that the action surface 421 keeps in contact with the inner wall of the air passage 100. The friction increasing component is fixedly arranged on the acting surface 421 and protrudes radially outwards to realize the friction fixation of the acting surface 421 and the air passage 100. Compared with the anchoring and stabbing fixing mode, the air duct 100 is prevented from being damaged and the possibility of inflammation of the air duct 100 is reduced on the premise that the fixing effect is guaranteed and the rollover risk is reduced. The friction increasing member may be, for example, a plurality of protrusions 422 arranged in sequence, each protrusion 422 being spherical crown shaped and convex as much as possible to facilitate positioning. The arrangement may be, for example, a straight arrangement, a triangular arrangement, or an array arrangement.

In one embodiment, referring to fig. 2, each anchor is crimped into a closed loop configuration. One part of each stock is linking arm 423, and the one end and the outer go-between 250 fixed connection of linking arm 423, the other end and the reverse side of acting surface 421 (for the reverse side of acting surface 421 contact air flue 100 inner wall) fixed connection for each stock curls into closed loop construction, has promoted stability, and further guarantees the effect of increasing the part that rubs.

In one embodiment, the support body 220 and the anchor 400 are deformable or flexibly connected. For example, the outer connection ring 250 and the inner connection ring 413 are connected and fixed by a memory wire or a hypotube, so that the axis of the support body 220 and the axis of the anchor 400 form an angle relatively, the overall posture is adaptive, and the applicable range of the airway 100 is wider. Specifically, since the actual condition of the airway 100 is complicated, there are many bends, the area in which the one-way flap can be accommodated is short, and when the length of the one-way flap is long, the blocking effect in the bent airway 100 is not good. Compared with the relatively fixed connection mode of the anchor 400 and the support body 220, the air duct 100 can adapt to the complex structure of the air duct 100, and better sealing is realized.

To disclose the interventional delivery and retrieval process of a retrievable one-way flap device, in one embodiment, referring to fig. 1a, 3, and 4, the one-way flap device has a compressed state for interventional delivery and a released state when in operation, wherein the semi-compressed state shown in fig. 3 refers to the support body 220 being in a compressed state and the anchor 400 being in a released state. Relative to the released state, the netpen structure is radially collapsed in the compressed state, and the distal 222 and proximal 221 ends of the support body 220 are further apart from each other.

In this embodiment, the opening angle of the recovery hook 211 is inclined toward the distal end 222 of the support 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 clamped with the recovery hook 211 so as to pull the recovery hook 211 to move. Furthermore, when the recovery pull ring 111 is engaged with the recovery hook 211, the interventional delivery system further comprises a support tube 120 which is relatively fixed with the recovery pull ring 111, the support tube 120 is movably sleeved outside the traction member 110, the recovery pull ring 111 extends out of the end of the far end of the support tube 120, the far end of the support tube 120 is provided with a fixing groove 121, the support tube 120 is engaged with the recovery pull ring 111 through the fixing groove 121 and abuts against the first connecting member 210 in the far end direction, on one hand, the support tube 120 can keep the recovery pull ring 111 stably connected with the first connecting member 210, and in addition, necessary axial driving force can be provided.

The recovery cannula 130 is also smaller than the radial dimensions of the support body 220, and the anchor 400 in the released state. The embodiment realizes the interventional delivery and recovery of the recoverable one-way valve device through the relative movement of the recovery sleeve 130 and the recovery pull ring 111. Specifically, the method comprises the following steps:

during interventional delivery, the anchor 400 is pushed out by the interventional delivery system through the recovery hook 211, is restored to a release state and is fixed on the inner wall of the airway 100; the support body 220 is then pushed out by the interventional delivery system through the retrieval hook 211, restored to a release state, and forms a closure with the diaphragm 230 for the airway 100, and the retrieval pull ring 111 is subsequently withdrawn to complete the release.

During recovery, the proximal end 221 of the support 220 is axially moved toward the human body oral side by the recovery hook 211, or the recovery cannula 130 is moved away from the human body oral side by the recovery hook 211. In the process, the support body 220 is deformed and folded by the radial acting 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 is gradually increased until the support body 220 is completely accommodated in the recovery sleeve 130; then the anchor 400 moves towards the human body oral cavity side or the recovery sleeve 130 continues to move away from the human body oral cavity side, the anchor 400 is radially stressed to be inwards deformed and separated from the airway 100, and recovery is completed.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims

1. A retrievable one-way valve assembly having opposite distal and proximal sides, comprising:

a support body integrally being a deformable mesh cage structure that converges in shape at its distal and proximal ends;

an anchor secured to a distal end of the support body;

2. The retrievable one-way valve device according to claim 1, wherein the membrane covers a portion of the support body on a proximal side thereof, the membrane having a free edge that is movable relative to the support body to control the degree of opening of the airway, the free edge being located at a peripheral edge of the support body and being located adjacent to a region of the support body having the greatest outer diameter.

3. The retractable one-way valve assembly of claim 2, wherein the support body comprises a plurality of support rods, all of which have one end converging to the first connector and the other end converging to a second connector, the anchor being secured to the second connector.

4. The recoverable one-way valve device according to claim 3, wherein all the support rods and the first connecting piece are in a split fixed or integrated structure, and the adapting structure is a hook, a connecting hole or an expanding head.

5. The retrievable one-way valve assembly according to claim 3, wherein the anchor comprises a plurality of radially spaced anchor rods, each of which has one end fixed relative to the second connector and the other end extending radially outwardly of the support body and terminating with a bifurcated multi-strand anchor barb.

6. The retractable one-way valve device of claim 5, wherein one end of each anchor rod is fixed to a third connecting piece in a converging manner, and the third connecting piece and the second connecting piece are of an integral structure or are fixed in a nesting manner.

7. The retractable one-way valve assembly of claim 1, wherein the anchor comprises a plurality of radially extending anchors, each anchor extending radially outward from the support body and having an active surface for engaging the inner wall of the airway, the active surface having a raised friction enhancing member thereon.

8. The retractable one-way valve assembly of claim 7, wherein each anchor is crimped into a closed loop configuration.

9. The retrievable unidirectional valve device according to any one of claims 1 to 8, wherein the support body is deformable or flexibly connected to the anchor.

10. The retrievable one-way flap device according to claim 9, wherein the one-way flap device has a compressed state for interventional delivery and a released state in operation, and wherein the netpen structure is radially collapsed in the compressed state and the distal and proximal ends of the support body are further away from each other relative to the released state.