One-way valve device for use in the airway

Abstract

The present application relates to a one-way valve device for use in an airway, having a distal side and a proximal side relative to each other, and comprising: a support body, which is a deformable mesh structure as a whole, and which flares and opens toward the proximal side; a diaphragm, which covers the support body and is used to control the degree of airway opening, and the diaphragm has a free edge that flexibly cooperates with the support body to control the degree of airway opening, the free edge extending beyond the flared edge of the mesh structure, and the portion extending beyond the flared edge forms a free band continuously distributed along the circumference of the support body; and an anchor member, which is fixed to a central portion connected to the mesh structure and located at the distal end of the support body. The free edge of the present application reduces the influence of the support body structure, has a larger margin of movement, and is more sensitive to opening and closing.

Description

Technical Field

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

[0005] The present application provides a one-way valve device for use in an airway, having opposite distal and proximal sides, comprising:

[0006] The support body is a deformable mesh cover structure as a whole, and the mesh cover structure is expanded and opened toward the proximal end side;

[0007] a diaphragm covering the support body for controlling the degree of airway patency, the diaphragm having a free edge that flexibly cooperates with the support body to control the degree of airway patency, the free edge extending beyond the flared edge of the mesh structure to form a free band continuously distributed along the circumference of the support body;

[0008] An anchor is fixed to the central portion of the mesh structure and is located at the distal end of the support body.

[0009] The free edge of the present application reduces the influence of the structure of the supporting body, has a larger margin of activity, and is more sensitive to opening and closing.

[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 width of the free band is 1.5 mm to 4 mm.

[0012] Optionally, the free bands are of equal width at the ends of the support rods.

[0013] Optionally, the thickness of the free band gradually decreases from the distal end to the proximal end.

[0014] Optionally, the support body includes a plurality of support rods, one end of all the support rods converges to the center of the mesh structure, and the other end radiates outward and tilts toward the proximal end.

[0015] Using multiple support rods to form a mesh cover can obtain an umbrella-shaped overall configuration, which is easy to compress or release. Each support rod can reduce the radial size after compression by utilizing the retraction and expansion principle of the umbrella ribs. The relatively independent support rods can reduce mutual traction and restraint, and the mesh cover structure is easier to fit or approach the inner wall of the trachea.

[0016] Optionally, the end of the support rod is a round head structure.

[0017] The round head structure avoids damage to the diaphragm and body tissues.

[0018] Optionally, the intra-airway one-way valve device further comprises a first connecting member, the first connecting member being located at the radial center of the mesh structure, one end of all support rods converging and fixed to the first connecting member, the first connecting member having an adapting structure for cooperating with an interventional delivery system;

[0019] 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.

[0020] 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.

[0021] Optionally, the one-way valve device has a loading state for interventional delivery, a compressed state for recovery, and a released state for operation;

[0022] In the released state, the flared edge of the mesh cover structure is located on the proximal side of the first connecting member.

[0023] In the loaded state, the support bars converge radially inward, and the first connecting member is located in the area enclosed by the mesh structure, that is, it does not extend out of the proximal side of the mesh structure, thereby avoiding an increase in the overall length of the one-way valve device and ensuring sufficient compliance during the interventional bending process.

[0024] Optionally, the support rod has a detour portion extending distally at a central portion adjacent to the mesh cover structure.

[0025] The provision of the detour portion can avoid the first connecting member in space, thereby optimizing the extension trend of the support rod.

[0026] Optionally, in the loaded state, the detour portion remains folded.

[0027] The axial length of the one-way valve device is further reduced, making it applicable to a wider range of airways.

[0028] Optionally, the anchoring member includes a plurality of anchor rods distributed radially, one end of each anchor rod converges and is fixed to the third connecting member, and the other end extends outward in the radial direction of the support body and has a forked multiple anchor barbs at the end;

[0029] The third connecting member and the first connecting member are an integral structure or are nested and fixed.

[0030] The multiple anchor spikes act on the inner wall of the airway to achieve the positioning of the anchor.

[0031] 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.

[0032] The friction-increasing component minimizes damage to the airway caused by the anchoring component.

[0033] Optionally, each anchor rod is curled into a closed loop structure.

[0034] The closed-loop structure improves the stability of the anchor, reduces isolated branches or spikes to a certain extent, and further improves safety.

[0035] 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

[0036] Figure 1 A schematic diagram of the three-dimensional structure of a one-way valve device in an embodiment of the application;

[0037] Figures 2a to 2c for Figure 1 Schematic diagrams of different angles of the one-way valve device after omitting the diaphragm shown in FIG;

[0038] Figure 3 This is a schematic diagram of the three-dimensional structure of an anchoring member in one embodiment of the present application;

[0039] Figure 4 This is a schematic structural diagram of a one-way valve device in a loaded state according to an embodiment of the present application;

[0040] Figure 5 This is a schematic structural diagram of a one-way valve device in a compressed state according to an embodiment of the present application;

[0041] The reference numerals in the figures are described as follows:

[0042] 100, airway; 110, traction member; 111, recovery pull ring; 120, support tube; 121, fixing groove; 130, recovery sleeve;

[0043] 300, one-way valve device; 301, proximal end; 302, distal end;

[0044] 310. First connecting member; 311. Recovery hook;

[0045] 320, support body; 321, support rod; 322, round cake; 323, roundabout portion;

[0046] 330, diaphragm; 331, free edge; 332, free zone;

[0047] 400, anchoring member; 410, anchor rod; 411, main anchor spike; 412, auxiliary anchor spike; 413, inner connecting ring; 420, anchor rod; 421, working surface; 422, protrusion; 423, connecting arm. DETAILED DESCRIPTION

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] The existing duckbill endobronchial valve (EBV) consists of a support mesh and two valves located in the middle of the mesh. When placed in the airway, the movement of the two valves enables one-way ventilation, blocking air from entering the treated lung lobe. This one-way ventilation is achieved by opening the two valves during exhalation and closing them during inhalation. However, the location of the two valves in the middle of the support mesh hinders the drainage of bronchial secretions. Another alternative, the umbrella-shaped endobronchial valve (IBV), consists of an umbrella-shaped support frame covered by a diaphragm and a diaphragm for airway closure. To facilitate intervention and retrieval, a retrieval connection extends from the middle of the umbrella-shaped support frame, and the axial length of this connection exceeds that of the umbrella-shaped support frame. Due to the complex and numerous bends in the airway, the area available for the one-way valve device is relatively short, limiting its wide applicability. Furthermore, the diaphragm of the umbrella-shaped endobronchial valve (IBV) is not very sensitive in opening and closing, and the airway closure effect is also insufficient.

[0053] See also Figure 1One embodiment of the present application provides a one-way valve device 300 for use in an airway. The one-way valve device has opposite distal and proximal sides and includes a support body 320, a diaphragm 330, and an anchor 400. The support body 320 is generally a deformable mesh structure that flares toward the proximal side. The diaphragm 330 covers the support body 320 and is used to control the degree of opening of the airway 100. The diaphragm 330 has a free edge 331 that flexibly cooperates with the support body 320 to control the degree of opening of the airway 100. The free edge 331 extends beyond the flared edge of the mesh structure, and the portion that extends beyond the mesh structure forms a free band 332 that is continuously distributed along the circumference of the support body 320. The anchor 400 is fixed to the center of the mesh structure and is located at the distal end of the support body 320.

[0054] In the various embodiments of the present application, the structural features of the support body 320, the diaphragm 330 and the anchor 400 are assumed to be in a released state unless otherwise specified. Deformable means that the one-way valve device can be compressed and stored in the interventional delivery system during interventional delivery or retrieval. The proximal end 301 or the proximal side described in the various embodiments of the present application refers to the end or side that is relatively close to or facing the surgical operator during intervention, and the distal end 302 or the distal side refers to the end or side that is relatively far away from or facing away from the surgical operator during intervention. The radial dimension of the proximal side of the support body 320 is larger than the radial dimension of the distal side, and the radial dimension changes gradually. The mesh cover structure itself has a large number of hollow areas, which can adapt to radial scaling and can be formed by weaving or cutting. Overall, the mesh cover structure is semi-open, that is, the support body 320 is open toward the proximal side as a whole.

[0055] The diaphragm 330 in this embodiment is made of a soft material and is coated on the mesh structure of the support body 320. The anchor 400 is anchored to the inner wall of the airway 100 to secure the one-way valve device. The free edge 331 is located at the periphery of the diaphragm. The free edge 331 controls the degree of opening of the airway 100 in the following manner: during inspiration, gas flows from the proximal end 301 to the distal end 302, and the diaphragm 330 is subjected to radial force outward, causing the free edge 331 to move closer to the inner wall of the airway 100, forming a barrier and preventing further gas from entering. During exhalation, gas flows from the distal end 302 to the proximal end 301, and internal gas and secretions cause the free edge 331 to be subjected to radial force inward and deform, forming an escape gap between the diaphragm 330 and the inner wall of the airway 100, allowing internal gas and secretions to be discharged through the gap between the diaphragm 330 and the inner wall of the airway 100, thereby achieving a one-way ventilation function.

[0056] The mesh cover structure itself is a grid structure with a hollow area, or multiple radially distributed rods, and its flared edge corresponds to the nearest side of the grid or the proximal end of the rod. The free edge 331 forms an annular free band 332 after passing over the flared edge of the mesh cover structure. Along the axial direction of the support body, the width L of the free band 332 is about 2 mm, for example, 1.5 mm to 4 mm.

[0057] In this embodiment, during inhalation or exhalation, the free edge 331 is less affected by the support body 320, has a larger margin of motion, and opens and closes more sensitively. Through this structural design, the one-way valve device, after being implanted in the lungs, can stably achieve one-way ventilation in the affected area, thereby reducing lung volume, inhibiting lung overinflation, and improving respiratory function.

[0058] The outer diameter of the mesh cover structure at the flared edge is smaller than the circumscribed circle diameter of the anchor. When the shape of the airway at the location is approximately cylindrical, after the anchor and the inner wall of the airway are supported and positioned, the abutting force between the flared edge and the inner wall of the airway of the mesh cover structure will be slightly reduced, thereby providing the necessary space for the floating of the free belt 332.

[0059] To further ensure the agility of free band 332's movement, its thickness can gradually decrease from the flared edge of the mesh structure toward the proximal end. Free band 332, ignoring airway compression and gravity, has a free state, which can also be understood as the intended initial shape during processing. In this free state, free band 332 has a more pronounced outward expansion tendency relative to the adjacent support portion.

[0060] See also Figure 1 and Figure 2a The support body 320 includes a plurality of support rods 321, one end of all the support rods converges to the center of the mesh structure, and the other end radiates outward and tilts toward the proximal side.

[0061] For example, one end of the support rod 321 is located in the center, and the other end is radiated outward and tilted toward the proximal end from the overall extension trend. The extension path of each support rod is a smooth curve, and the number of support rods is 4 to 10, for example, 6 or 8. The support rods ensure the overall shape of the support body 320 and the close fit between the diaphragm 330 and the inner wall of the airway 100. In terms of material, the support rods are made of elastic memory metal material.

[0062] Furthermore, the proximal ends of the support rods are defined as the distal ends, and the distal ends of the support rods have rounded ends. Together, the distal ends of the support rods form the edge of the mesh structure of the support body 320. It will be appreciated that this rounded end structure increases the area of ​​attachment between the support rods 321 and the diaphragm 330. Specifically, the rounded end structure does not necessarily require a standard circular or spherical shape; it simply means that the proximal end of the rounded end structure extends generally along an arc. The actual shape of the rounded end structure can be, for example, the circular disc 322 shown in the figure.

[0063] See also Figure 2a The one-way valve device in the airway also includes a first connecting member 310, which is located in the center of the mesh structure. One end of all support rods converges and is fixed to the first connecting member 310. The first connecting member 310 has an adapter structure for cooperating with the interventional delivery system.

[0064] Furthermore, all support rods and the first connecting member 310 are fixed in a separate or integrated structure, and the adapting structure is a hook, a connecting hole, or an enlarged head. For example, the first connecting member 310 is a hollow round tube, and the adapting structure on the first connecting member 310 is a recovery hook 311.

[0065] The support rod 321 has a detour portion 323 extending distally near the center of the mesh structure. The support rod 321 extends from the center toward the distal end 302, then smoothly curves in a nearly arc-shaped manner before extending toward the proximal end 301. This curve is the detour portion 323. Detour portion 323 expands radially outward during the curve.

[0066] See also Figure 2a The anchoring member 400 includes a plurality of anchor rods 410 distributed radially, one end of each anchor rod being fixed to a third 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;

[0067] The center of the radial distribution of anchors 400 is one end of an anchor rod 410 fixed relative to the first 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 320 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 320 is located; the secondary anchor spike 412 extends perpendicular to the primary anchor spike 411.

[0068] See also Figure 2a The third connecting member is integrally formed with the first connecting member 310 or is fixedly nested therewith. For example, the third connecting member is an inner connecting ring 413, which is nested and fixed to the first connecting member 310 or is fixedly welded thereto.

[0069] In one embodiment, see Figure 3 The anchor 400 includes multiple radially distributed anchor rods 420. Each anchor rod 420 extends radially outward from the support body 320 and has an active surface 421 that engages the inner wall of the airway 100. The active surface 421 includes a protruding friction-enhancing component. Each anchor rod 420 is 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 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.

[0070] In one embodiment, see Figure 2a , the support body 320 and the anchor 400 can be deformed or flexibly connected. For example, the first connecting member 310 and the inner connecting ring 413 are connected and fixed by a memory wire or a sea wave tube, allowing the axis of the support body 320 to form an angle with the axis of the anchor 400 relative to each other, and the overall posture is adaptive, making it applicable to a wider range of airways 100. Specifically, when the length of the one-way valve is long, the sealing effect in the curved airway is not good. Compared with the relatively fixed connection between the anchor 400 and the support body 320, this embodiment can adapt to complex airway 100 structures, can achieve the sealing of curved airways, and further enhance flexibility.

[0071] In one embodiment, see Figure 3 As shown in the figure, each anchor rod is partly connected to a connecting arm 423. One end of the connecting arm 423 is fixedly connected to the inner connecting ring 413, and the other end is fixedly connected to the opposite side of the active surface 421 (the opposite side of the active surface 421 that contacts the inner wall of the airway 100). This allows each anchor rod to be curled into a closed loop structure, improving stability and further ensuring the effectiveness of the friction-increasing component.

[0072] To disclose the interventional delivery and retrieval process of the one-way valve device, in one embodiment, see Figure 2a 、 Figure 4 ,and Figure 5 The one-way valve device has a release state during operation, a loading state for interventional delivery, and a compression state during retrieval.

[0073] See also Figure 5The opening angle of the retrieval hook 311 is inclined toward the distal end of the support body 320. The side wall of the first connecting member 310 is cut, and its head position forms the retrieval hook 311 as a whole. The interventional delivery system may include a traction member 110, the distal end of which is provided with a retrieval pull ring 111. The retrieval pull ring 111 acts on the retrieval hook 311 to enable the interventional delivery system to retract the one-way valve device. The interventional delivery system also includes a support tube 120, which is movably mounted on the outside of the traction member 110. The distal end of the support tube 120 is provided with a fixing groove 121, which engages with the retrieval pull ring 111. The support tube 120 is pressed against the first connecting member 310 in the distal direction. On the one hand, the support tube 120 can limit the radial position of the retrieval pull ring 111 to maintain a stable connection between the retrieval pull ring 111 and the first connecting member 310, and can also provide the necessary axial driving force. The operation of the one-way valve device is achieved through the cooperation between the recovery sleeve 130, the support tube 120 and the recovery pull ring 111.

[0074] In the loaded state, the flared edge of the mesh structure is radially gathered inwardly within the recovery sleeve 130, and the detour portion 323 remains folded.

[0075] During interventional delivery, the traction member 110, support tube 120, retrieval cannula 130, and the loaded one-way valve device are transported to a designated location. The one-way valve device is then released through the distal end of the retrieval cannula 130. After the retrieval cannula 130 is released from its restraints, the anchor 400 and the mesh structure return to their released state. The anchor 400 is fixed relative to the airway 100, and the mesh structure and diaphragm 330 together form a seal to block the airway 100. After the release is complete, the support tube 120 releases the radial position restraint on the retrieval ring 111, allowing the retrieval ring 111 to move distally and exit from the retrieval hook 311.

[0076] When recovery is required, the support body 320 and the anchor 400 are sequentially received into the recovery sleeve 130 through the relative movement of the one-way valve device and the recovery sleeve 130. The edge of the recovery sleeve 130 acts on the inner side of the smooth turning of the detour portion 323, and the detour portion 323 further guides each support rod to be straightened. The one-way valve device is received into the recovery sleeve 130, and the detour portion 323 remains straightened. Figure 5 As shown, in the compressed state, the anchor rod 410 is converged, and the support rod 321 is converged and surrounded by the outer periphery of the anchor rod 410.

[0077] 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.

[0078] 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 one-way valve device for use in an airway, having opposite distal and proximal sides, characterized in that: The one-way flap device has a loading state for interventional delivery, a compressed state for recovery, and a released state for operation, and the one-way flap device includes: The support body is a deformable mesh cover structure as a whole, and the mesh cover structure is expanded and opened toward the proximal end side; a diaphragm covering the support body for controlling the degree of airway patency, the diaphragm having a free edge that flexibly cooperates with the support body to control the degree of airway patency, the free edge extending beyond the flared edge of the mesh structure to form a free band continuously distributed along the circumference of the support body; An anchor is fixed to the central portion of the mesh structure and is located at the distal end of the support body.

2. The one-way valve device for use in an airway 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 central part of the mesh cover structure, and the other end radiates outward and tilts toward the proximal end.

3. The one-way valve device for use in an airway according to claim 2, characterized in that: The end of the support rod is a round head structure.

4. The one-way valve device for use in an airway according to claim 3, characterized in that: The one-way valve device in the airway further includes a first connecting member, which is located at the radial center of the mesh structure, and one end of all the support rods converges and is fixed to the first connecting member, and the first connecting member has an adapting structure for cooperating with the interventional delivery system; 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.

5. The one-way valve device for use in an airway according to claim 4, characterized in that: In the released state, the flared edge of the mesh cover structure is located on the proximal side of the first connecting member.

6. The one-way valve device for use in an airway according to claim 5, characterized in that: The support rod has a distally extending detour portion at a central portion adjacent to the mesh cover structure.

7. The one-way valve device for use in an airway according to claim 6, characterized in that: In the loaded state, the detour portion remains folded.

8. The one-way valve device for use in an airway according to claim 4, characterized in that: The anchoring member comprises a plurality of anchor rods distributed radially, one end of each anchor rod being fixed to a third connecting member, and the other end extending outward in the radial direction of the support body and having a plurality of forked anchor spikes at the end; The third connecting member and the first connecting member are an integral structure or are nested and fixed.

9. The one-way valve device for use in an airway according to claim 4, characterized in that: The anchoring member comprises 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 cooperating with the inner wall of the airway, wherein the action surface is provided with an outwardly convex friction-increasing component.

10. The one-way valve device for use in an airway according to claim 9, characterized in that: Each anchor rod is curled into a closed loop structure.

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