CN217488740U - One-way valve device used in air passage - Google Patents

Abstract

The present application relates to a one-way valve device for use in an airway, having opposite distal and proximal sides, comprising: the support body is a deformable mesh enclosure structure on the whole, and the mesh enclosure structure is flared towards the near-end side and is open; the diaphragm is covered on the support body and used for controlling the opening degree of the air passage, the diaphragm is provided with a free edge which is movably matched with the support body so as to control the opening degree of the air passage, and the free edge passes over the flaring edge of the mesh cover structure and partially forms a free belt which is continuously distributed along the circumferential direction of the support body; and the anchor is fixed at the central part connected with the mesh enclosure structure and positioned at the far end side of the support body. The free reason of this application has weakened the structural influence who receives the supporter, has bigger allowance for movement, and the switching is more sensitive.

Description

One-way valve device used in air passage

Technical Field

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

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 2017 global initiative for chronic obstructive pulmonary disease (Gold guideline) update recommends endoscopic lung volume-reduction (ELVR) to be selectively applicable to severe COPD patients, safer than LVRS, and especially 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 because the drug therapy has high price, poor effect, high risk of lung volume reduction surgery, large harm to human body and high death rate. The existing one-way valve flaps mainly comprise duckbill 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.

SUMMERY OF THE UTILITY MODEL

In view of the above, it is necessary to provide a one-way valve device to solve the above technical problems.

The present application provides a one-way valve device for use in an airway, having opposite distal and proximal sides, comprising:

the support body is a deformable mesh enclosure structure on the whole, and the mesh enclosure structure is flared towards the near-end side and is open;

the diaphragm is covered on the support body and used for controlling the opening degree of the air passage, the diaphragm is provided with a free edge which is movably matched with the support body so as to control the opening degree of the air passage, and the free edge passes over the flaring edge of the mesh cover structure and partially forms a free belt which is continuously distributed along the circumferential direction of the support body;

and the anchor is fixed at the central part connected with the mesh enclosure structure and positioned at the far end side of the support body.

The free reason of this application has weakened the structural influence who receives the supporter, has bigger allowance for movement, and the switching is more sensitive.

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 width of the free band is 1.5 mm-4 mm.

Optionally, the free bands are equal in width at the end of each support rod.

Optionally, the thickness of the free band decreases from the distal end to the proximal end.

Optionally, the supporter includes many spinal branchs vaulting pole, and the one end of all bracing pieces assembles to the central point of screen panel structure, other end radiation outwards distributes and inclines towards the near-end side.

The mesh enclosure is formed by a plurality of support rods, so that an umbrella-shaped integral structure can be obtained, the mesh enclosure is convenient to compress or release, the radial size of each support rod after compression can be reduced by using the retraction and extension principle of umbrella ribs, traction and constraint can be reduced among the support rods which are relatively independent, and the mesh enclosure structure is more easily attached to or approaches the inner wall of a trachea.

Optionally, the tail end of the supporting rod is of a round head structure.

The round head structure avoids damage to the diaphragm and the tissues in the body.

Optionally, the one-way valve device in the air passage further includes a first connecting piece, the first connecting piece is located at a radial central position of the mesh enclosure structure, one end of each of the support rods is converged and fixed to the first connecting piece, and the first connecting piece is provided with an adapting structure used for being matched with an interventional conveying system;

all the support rods and the first connecting piece are of split fixing or integrated structures, and the adaptive structures are hooks, connecting holes or expansion heads.

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 one-way valve device has a loading state for interventional delivery, a compression state for recovery and a release state during operation;

in the released state, the flared edge of the mesh enclosure structure is located on the proximal side of the first connection member.

Under the loading state, each support bar gathers together radially inwards, and first connecting piece is in the region that the screen panel structure was gathered together, does not extend the near-end side of screen panel structure promptly, can avoid the increase of one-way valve device overall length, guarantees sufficient compliance when intervene and transfer the curved in-process.

Optionally, the support bar has a circuitous portion extending distally adjacent a central portion of the mesh enclosure structure.

The first connecting piece can be avoided in space through the arrangement of the roundabout part, and the extending trend of the supporting rod is optimized.

Optionally, the circuitous portion remains folded in the loaded state.

Further reducing the axial length of the one-way valve device and enabling the applicable air passage range to be wider.

Optionally, the anchor comprises a plurality of anchor rods distributed radially, one end of each anchor rod is converged and fixed to the third connecting piece, the other end of each anchor rod extends radially outwards from the support body, and the tail end of each anchor rod is provided with a plurality of forked anchor stabs;

the third connecting piece and the first connecting piece are of an integral structure or are fixed in a nesting mode.

The multiple anchor punctures act on the inner wall of the airway to realize the positioning of the anchor.

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 passage as much as possible.

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.

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. 1 is a schematic perspective view of a one-way valve device according to an embodiment of the present invention;

FIGS. 2 a-2 c are schematic views of the one-way valve device of FIG. 1 at different angles with the diaphragm omitted;

FIG. 3 is a perspective view of an anchor according to an embodiment of the present disclosure;

FIG. 4 is a schematic structural view of a one-way valve device in a loaded state according to an embodiment of the present disclosure;

FIG. 5 is a schematic view of a compressed state of a one-way valve device according to an embodiment of the present disclosure;

the reference numbers in the figures are 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;

300. a one-way flap device; 301. a proximal end; 302. a distal end;

310. a first connecting member; 311. the hook is recovered;

320. a support body; 321. a support bar; 322. a cake; 323. a circuitous part;

330. a diaphragm; 331. a free edge; 332. a free band;

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.

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 obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort belong to 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 air passage. 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. Because the environment in the air flue is complex, a plurality of bends exist, and the area for accommodating the one-way valve device is short, so the application range of the one-way valve device is not wide enough. And the diaphragm of the umbrella-shaped endobronchial valve IBV is not sensitive to open and close, and the plugging effect on the air passage is not good enough.

Referring to fig. 1, an embodiment of the present application provides a one-way valve device 300 for use in an airway, the one-way valve device having opposite distal and proximal sides, comprising a support body 320, a septum 330, and an anchor 400. The support body 320 is a deformable mesh enclosure structure as a whole, and the mesh enclosure structure is flared and opened towards the near end side; the diaphragm 330 is covered on the support body 320 for controlling the opening degree of the air passage 100, the diaphragm 330 has a free edge 331 movably matched with the support body 320 for controlling the opening degree of the air passage 100, and the free edge 331 passes over the flaring edge of the mesh enclosure structure and partially forms a free belt 332 continuously distributed along the circumferential direction of the support body 320; the anchor 400 is fixed to the central portion of the mesh structure at the distal end side of the supporting body 320.

In the embodiments of the present application, the support 320, the membrane 330 and the anchor 400 are configured to be released by default without specific description. The deformable means that the one-way valve device can be compressed and stored in an interventional conveying system when being delivered or recovered. The proximal end 301 or the proximal side in the embodiments of the present application refers to an end or a side relatively close to or toward the operator at the time of the intervention, and the distal end 302 or the distal side refers to an end or a side relatively far from or away from the operator at the time of the intervention. The radial dimension of the proximal side of support body 320 is larger than the radial dimension of the distal side, and the radial dimension gradually changes. The screen panel structure itself has more fretwork region, can adapt to radial scaling, can adopt the mode of weaving or cutting to form, looks the semi-open of screen panel structure on the whole, and the supporter 320 is opened towards near-end side in the whole promptly.

In this embodiment, the diaphragm 330 is made of a soft material, the diaphragm 330 is wrapped on the mesh enclosure structure of the support body 320, and the anchor 400 is anchored on the inner wall of the airway 100, so as to fix the one-way valve device. The free edge 331 is located at the periphery of the diaphragm, and the way in which the free edge 331 controls the opening degree of the airway 100 is: when the gas flows from the near end 301 to the far end 302 during inhalation, the diaphragm 330 is stressed towards the radial outside, so that the free edge 331 is closer to the inner wall of the gas passage 100 to form a barrier, and the gas cannot enter continuously; when the patient exhales, gas flows from the far end 302 to the near end 301, the free edge 331 is stressed and deformed radially inwards by internal gas and secretion, and the diaphragm 330 and the inner wall of the airway 100 form an avoiding gap, so that the internal gas and the secretion can be discharged from the gap between the diaphragm 330 and the inner wall of the airway 100, and the one-way ventilation function is realized.

The mesh enclosure structure is a mesh structure with a hollow area or a plurality of rods distributed in a radiation mode, the flaring edges of the mesh structure are correspondingly the nearest side edges of the meshes or the near end ends of the rods, the free edges 331 cross the flaring edges of the mesh enclosure structure to form annular free belts 332, and the width of each free belt 332 is about 2mm, for example, 1.5 mm-4 mm, along the axial direction of the support body.

In this embodiment, during inhalation or exhalation, the free edge 331 is less affected by the support 320, and has a larger movement margin, and the free edge 331 is more sensitive to open and close. Through the structural design, the unidirectional valve device can stably realize unidirectional ventilation of a focus area after being implanted into the lung, so as to achieve the purposes of reducing lung volume and inhibiting over-expansion of the lung, and improve the respiratory function.

The external diameter of the mesh enclosure structure at the flaring edge is smaller than the diameter of the circumscribed circle of the anchoring piece, when the shape of the air passage at the position is similar to a cylinder, the anchoring piece and the inner wall of the air passage support and position, the abutting acting force of the mesh enclosure structure between the flaring edge and the inner wall of the air passage can be slightly reduced, and thus necessary space is provided for floating of the free belt 332.

To further ensure the sensitivity of the free band 332 movement, the thickness of the free band 332 may gradually decrease from the flared edge of the mesh enclosure structure toward the proximal side. The free band 332 has a free state regardless of the air passage compression and gravity, and can be understood as an initial shape expected during processing. In the free state, the free band 332 has a more pronounced tendency to flare relative to adjacent support sites.

Referring to fig. 1 and 2a, the supporting body 320 includes a plurality of supporting rods 321, one end of each of the supporting rods converges to a central portion of the mesh enclosure structure, and the other end of each of the supporting rods radially outwardly extends and inclines toward the proximal end.

For example, one end of the support rod 321 is located at the center, and the other end is radially outwardly distributed and inclined toward the proximal end side as viewed from the overall extension tendency. The extending path of each supporting rod is a smooth curve, the number of the supporting rods is 4-10, for example, the number of the supporting rods is 6 or 8. The support rods ensure the overall shape of the support body 320 and the close fit of the diaphragm 330 to the inner wall of the airway 100. From the material, the support rod is made of elastic memory metal material.

Further, the proximal ends of the support rods are defined as the ends, the ends of the support rods are rounded, and the ends of the support rods together form the edge of the mesh enclosure structure of the support body 320. It will be appreciated that the rounded configuration may increase the holding area for the support rod 321 and the diaphragm 330. In particular, the rounded head structure is not required to be a standard circle or sphere, meaning only that the proximal side of the rounded head structure extends generally along an arc, and the actual shape of the rounded head structure may be, for example, the pie 322 shown in the figures.

Referring to fig. 2a, the one-way valve device in airway further comprises a first connecting member 310, the first connecting member 310 is located at the central portion of the mesh enclosure structure, one end of each of the support rods is converged and fixed to the first connecting member 310, and the first connecting member 310 has an adapting structure for matching with an interventional delivery system.

Further, all the support rods and the first connecting member 310 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 first connector 310 is a hollow circular tube, and the adaptive structure on the first connector 310 is a recycling hook 311.

The support bar 321 is provided with a detour 323 extending distally adjacent to the central portion of the mesh enclosure structure. The supporting rod 321 extends from the central portion to the distal end 302, and then extends to the proximal end 301 after going through a smooth turn of an approximate arc, wherein the turn is the winding portion 323. The detour 323 expands radially outwards during the turn.

Referring to fig. 2a, the anchor 400 comprises a plurality of radially distributed anchor rods 410, one end of each anchor rod is converged and fixed to the third connecting member, and the other end of each anchor rod extends radially outwards of the support body and is provided with a plurality of diverged anchor thorns at the tail end;

the center of the radial distribution of anchor 400 is the end of anchor rod 410 fixed opposite the first 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 320 and penetrates into the inner wall of the air channel 100 for integral positioning; the secondary anchors 412 abut against the inner wall of the airway 100 to prevent rollover of the needle when the needle is too deep. Specifically, the extending direction of the main anchor 411 is perpendicular to a section of the inner wall of the airway 100 where the support body 320 is located; the secondary anchor 412 extends in a direction perpendicular to the primary anchor 411.

Referring to fig. 2a, the third connecting member is integrally formed with or nestingly secured to the first connecting member 310. For example, the third connection element employs an inner connection ring 413, and the inner connection ring 413 is fixed to the first connection element 310 in a nested manner or fixed to the first connection element 310 by welding.

In one embodiment, referring to fig. 3, the anchor 400 includes a plurality of radially spaced anchor rods 420, each anchor rod 420 extending radially outward from the support body 320 and having an active surface 421 for engaging the inner wall of the airway 100, the active surface 421 having a convex friction increasing member thereon. Each anchor rod 420 has an axis in space and is axisymmetrical, 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 channel 100. Compared with the anchoring and fixing mode, the embodiment avoids the damage to the air passage 100 and reduces the possibility of inflammation of the air passage 100 on the premise of ensuring the fixing effect and reducing the rollover risk. The friction increasing member may be, for example, a plurality of protrusions 422 arranged in sequence, each protrusion having a spherical crown shape and being convex as much as possible to facilitate positioning. The arrangement may be, for example, a linear arrangement, a triangular arrangement, or an array arrangement.

In one embodiment, referring to fig. 2a, the support 320 is deformable or flexibly connected to the anchor 400. For example, the first connector 310 and the inner ring 413 are fixed by memory wire or hypotube connection, allowing the axis of the support body 320 to form an angle with respect to the axis of the anchor 400, and the overall posture to be adaptive, making it suitable for a wider range of airway 100. In particular, when the length of the one-way flap is long, the blocking effect in the curved airway is poor. Compared with the relatively fixed connection mode of the anchor 400 and the support body 320, the air duct 100 can adapt to the complex structure of the air duct 100, can realize the blockage of the bent air duct, and further enhances the flexibility.

In one embodiment, referring to fig. 3, each anchor is crimped into a closed loop configuration. As shown in the figure, a part of each anchor rod is a connecting arm 423, one end of the connecting arm 423 is fixedly connected with the inner connecting ring 413, and the other end of the connecting arm 423 is fixedly connected with the reverse surface of the acting surface 421 (the reverse surface contacting with the inner wall of the air passage 100 relative to the acting surface 421), so that each anchor rod is curled into a closed loop structure, the stability is improved, and the acting effect of the friction increasing component is further ensured.

To disclose the interventional delivery and retrieval process of the one-way flap device, in one embodiment, referring to fig. 2a, 4, and 5, the one-way flap device has a release state when in operation, a loading state for interventional delivery, and a compressed state when in retrieval.

Referring to fig. 5, the opening angle of the recovery hook 311 is inclined toward the distal end of the supporting body 320, the sidewall of the first connecting member 310 is cut, and the recovery hook 311 is integrally formed at the head portion thereof. The interventional delivery system may include a pull member 110 with a recovery pull ring 111 at a distal end thereof, the recovery pull ring 111 acting on a recovery hook 311 to effect withdrawal of the one-way flap device from the interventional delivery system. The interventional delivery system further comprises a support tube 120, the support tube 120 is movably sleeved outside the traction member 110, a fixing groove 121 is formed in the distal end of the support tube 120, and the fixing groove 121 is engaged with the recovery pull ring 111. The support tube 120 is disposed against the first connector 310 in a distal direction, and the support tube 120 can limit the radial position of the retrieving tab 111 to maintain the retrieving tab 111 stably connected to the first connector 310, and can provide the necessary axial pushing force. The operation of the one-way valve device is realized by the mutual cooperation of the recovery sleeve 130, the support tube 120 and the recovery pull ring 111.

In the stowed condition, the flared edge of the mesh enclosure structure is gathered radially inward within the recovery sleeve 130, and the circuitous portion 323 remains folded.

During interventional delivery, the traction member 110, the support tube 120, the recovery sleeve 130 and the loaded unidirectional valve device are delivered to a designated position, the unidirectional valve device is released through the distal end port of the recovery sleeve 130, the anchoring member 400 and the mesh enclosure structure are both restored to a released state after the constraint of the recovery sleeve 130 is released, the anchoring member 400 and the airway 100 are relatively fixed, and the mesh enclosure structure and the diaphragm 330 together form a seal for the airway 100. After the release is completed, the support tube 120 is released from the restriction on the radial position of the recovery tab 111, and the recovery tab 111 moves to the distal end and exits from the recovery hook 311.

When recovery is required, support body 320 and anchor 400 are sequentially received into recovery cannula 130 by relative movement of one-way flap device and recovery cannula 130. The edge of the recycling sleeve 130 acts on the inner side of the smooth turn of the roundabout part 323, and the roundabout part 323 further guides each support rod to straighten. The one-way valve device is housed in the recovery sheath 130, and the bypass portion 323 is kept straight. As shown in fig. 5, in the compressed state, the anchor rod 410 is contracted, and the support rod 321 is contracted and gathered around the outer periphery of the anchor rod 410.

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 (10)

1. A one-way valve device for use in an airway having opposite distal and proximal sides, comprising:

the support body is a deformable mesh enclosure structure on the whole, and the mesh enclosure structure is flared towards the near-end side and is open;

the diaphragm is covered on the support body and used for controlling the opening degree of the air passage, the diaphragm is provided with a free edge which is movably matched with the support body so as to control the opening degree of the air passage, and the free edge passes over the flaring edge of the mesh cover structure and partially forms a free belt which is continuously distributed along the circumferential direction of the support body;

and the anchor is fixed at the central part connected with the mesh enclosure structure and positioned at the far end side of the support body.

2. The one-way valve device for use in an airway as claimed in claim 1 wherein the support body comprises a plurality of support rods, one end of each support rod converges to a central portion of the mesh enclosure structure, and the other end radially outwardly and slants towards a proximal side.

3. The one-way valve device for use in an airway as claimed in claim 2 wherein the support rod terminates in a rounded head.

4. The device as claimed in claim 3, further comprising a first connecting member located at a radial center of the mesh enclosure structure, wherein one end of each of the support rods is fixed to the first connecting member, and the first connecting member has an adapting structure for cooperating with an interventional delivery system;

all the support rods and the first connecting piece are of split fixing or integrated structures, and the adaptive structures are hooks, connecting holes or expansion heads.

5. The one-way valve device for use in an airway as claimed in claim 4 wherein the one-way valve device has a loading state for interventional delivery, a compressed state for retrieval and a released state in operation;

in the released state, the flared edge of the mesh enclosure structure is located on the proximal side of the first connection member.

6. The one-way valve device for use in an airway as claimed in claim 5 wherein the support bar has a distally extending circuitous portion adjacent a central portion of the mesh cage structure.

7. The one-way valve device for use in an airway as claimed in claim 6 wherein the circuitous portion remains folded in the stowed condition.

8. A one-way valve device used in the air flue according to claim 4, wherein the anchoring member comprises a plurality of radially distributed anchor rods, one end of each anchor rod is converged and fixed to the third connecting member, the other end of each anchor rod extends outwards in the radial direction of the supporting body, and the tail end of each anchor rod is provided with a plurality of bifurcate anchor stabs;

the third connecting piece and the first connecting piece are of an integral structure or are fixed in a nesting mode.

9. A one-way valve device for use in an airway as claimed in claim 4 wherein the anchor comprises a plurality of radially extending anchor rods each extending radially outwardly of the support body and having an active surface for engaging the inner wall of the airway, the active surface having a convex friction increasing portion thereon.

10. A one-way valve device for use in an airway as claimed in claim 9 wherein each anchor is crimped into a closed loop configuration.

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