阅读说明：本技术 支气管瓣膜 (Bronchial valve ) 是由 任凯炳 朱泽荀 王伦 姚瑶 李俊菲 于 2021-07-29 设计创作，主要内容包括：本发明涉及一种支气管瓣膜,支气管瓣膜包括支架、瓣膜组件以及拉索。其中,支架具有相对的近端以及远端,支架形成有供气流流通的通道。多个瓣叶的一端均连接至支架上,多个瓣叶的另一端均为自由端,多个瓣叶依次相邻设置,瓣膜组件具有闭合状态与打开状态,在闭合状态下,相邻瓣叶的相互抵接以封堵通道,在打开状态时,相邻的瓣叶相分离以打开通道,所述拉索与所述瓣膜组件连接,所述拉索用于控制所述瓣叶的状态或位置,使所述通道呈单向开启。上述支气管瓣膜增大了打开状态下的开口空间,便于肺内气体与分泌物排出,并且在闭合状态下具有良好的气密性,避免支气管瓣膜被被气流反向吹开。(The invention relates to a bronchial valve, which comprises a bracket, a valve assembly and a pull rope. Wherein the holder has opposite proximal and distal ends, the holder defining a channel for the flow of gas therethrough. The valve component is provided with a closed state and an opened state, the adjacent valve blades are mutually abutted to block the channel, the adjacent valve blades are separated to open the channel when the valve component is in the opened state, the guy cable is connected with the valve component, and the guy cable is used for controlling the state or the position of the valve blades to enable the channel to be opened in a one-way mode. The bronchial valve increases the opening space in the opening state, is convenient for the discharge of gas and secretion in the lung, has good air tightness in the closing state, and avoids the bronchial valve from being blown open reversely by airflow.)

1. A bronchial valve, comprising:

a bracket formed with a channel through which a gas stream flows;

a valve assembly including a plurality of leaflets, each of the plurality of leaflets being connected at one end to the stent and at another end to a free end, the valve assembly having a closed state in which adjacent leaflets abut one another to occlude the passageway and an open state in which adjacent leaflets separate to open the passageway; and the number of the first and second groups,

the pull rope is connected with the valve component and used for controlling the state or position of the valve leaflet to enable the channel to be opened in a one-way mode.

2. The bronchial valve of claim 1, wherein the pull cable is disposed between a proximal end of the stent and the valve assembly, and wherein one end of the pull cable is connected to the stent and the other end of the pull cable is connected to the leaflet.

3. The bronchial valve of claim 1, wherein the stent comprises a plurality of rods spaced apart and a connector for connection to a delivery mechanism, the rods each having a proximal end connected to the connector.

4. The bronchial valve of claim 1, wherein the stent has a support section and a valve section connected to a distal end of the support section, the support section having a diameter greater than a diameter of the valve section, the support section for abutting against an inner wall of a bronchus, the valve assembly being disposed in the valve section.

5. The bronchial valve of claim 4, further comprising a sealing membrane covering at least a portion of a periphery of the support segment and at least a portion of a periphery of the valve segment, the valve assembly being coupled to the sealing membrane of the valve segment.

6. The bronchial valve of claim 1, wherein free end edges of the leaflets are provided with folds that are raised towards a proximal end of the stent or raised towards a distal end of the stent, and the folds of adjacent leaflets abut each other when the valve assembly is in the closed state.

7. The bronchial valve of claim 1, wherein a free end edge of the leaflets is provided with a skirt, and the skirt overlaps adjacent leaflets when the valve assembly is in the closed state.

8. The bronchial valve of claim 2, wherein the stent is provided with a first connecting portion, the leaflet is provided with a second connecting portion, one end of the pull cable is connected to the first connecting portion, and the other end of the pull cable is connected to the second connecting portion.

9. The bronchial valve of claim 8, wherein the first connection portion is movably connected to the stent, and the state of the leaflet is adjusted by the position of the first connection portion on the stent.

10. The bronchial valve of claim 8, wherein the first connection portion is provided with a first connection hole, the second connection portion is provided with a second connection hole, one end of the stay is connected to the first connection hole, and the other end of the stay is connected to the second connection hole.

11. The bronchial valve of claim 10, wherein the pull cable comprises a first wire member and a second wire member arranged side by side, one end of the first wire member and one end of the second wire member together form a connection ring, the connection ring is inserted into the second connection hole, and the other end of the first wire member and the other end of the second wire member both pass through the first connection hole and then are connected with the limiting member.

12. The bronchial valve of claim 10, wherein the pull cable comprises a connection section, one end of the connection section is connected with a first ring portion, the other end of the connection section is connected with a second ring portion, the first ring portion is configured to be sleeved on the first connection hole, and the second ring portion is configured to be sleeved on the second connection hole.

13. The bronchial valve of claim 12, wherein the connecting section, the first loop portion, and the second loop portion are an integrally bent structure.

14. The bronchial valve of any one of claims 1 to 13, wherein the plurality of pull cables are connected to the stent at intervals at one ends thereof, and the plurality of pull cables are connected to the leaflets at the other ends thereof in a one-to-one correspondence.

Technical Field

The invention relates to the technical field of medical instruments, in particular to a bronchial valve.

Background

Chronic Obstructive Pulmonary Disease (COPD) is a major lethal cause in humans, and advanced emphysema is one of the causes of COPD, characterized by hypo-elasticity of airways distal to the terminal bronchioles, hyper-distension, gas filling and enlargement of lung volume or pathological conditions accompanied by destruction of airway walls. The current treatment of emphysema generally comprises two main categories of medical treatment and surgical treatment. Internal treatment includes oxygen inhalation, lung infection prevention, bronchial spasmolysis and the like, and has very limited effect. The surgical operation comprises lung volume reduction operation, lung bullae excision, lung transplantation and the like. Although surgery can reduce hyperfunction of lung, avoid dyspnea, improve exercise endurance and improve long-term survival in some patients, it has been greatly limited due to the invasiveness of surgery, serious complications, high costs, and the like.

To overcome the above difficulties, Bronchoscopic Lung Volume Reduction (BLVR) based on surgical lung volume reduction surgery mechanisms has come into force, including circling lung volume reduction, bronchial heat steam ablation, airway bypass stents, bio-gel lung volume reduction, and endobronchial valvuloplasty. The principle of endobronchial valvuloplasty is to insert the valve into the bronchus of the lung through a bronchoscope to block the lobes of emphysema, so that part or all of the lobes can be prevented from opening, and over-expansion of the lobes can be reduced. The endobronchial valve is a one-way valve, and a one-way flow channel is formed after implantation, so that residual gas and secretions can be smoothly discharged while the gas is prevented from entering a target lung lobe.

The space is less after traditional bronchus inner flap opens, is unfavorable for the secretion to discharge to the gas tightness is not good after the closure, is blown open by the air current reverse easily, leads to the shutoff inefficacy to the bronchus.

Disclosure of Invention

In view of the above, there is a need for a bronchial valve that increases the open space in the open state to facilitate the discharge of air and secretions in the lung, and has good air tightness in the closed state to avoid the problem of blockage failure of the bronchus caused by the bronchus valve being blown open by the airflow in the opposite direction.

The present application provides a bronchial valve comprising:

a bracket formed with a channel through which a gas stream flows;

a valve assembly including a plurality of leaflets, each of the plurality of leaflets being connected at one end to the stent and at another end to a free end, the valve assembly having a closed state in which adjacent leaflets abut one another to occlude the passageway and an open state in which adjacent leaflets separate to open the passageway; and the number of the first and second groups,

the pull rope is connected with the valve component and used for controlling the state or position of the valve leaflet to enable the channel to be opened in a one-way mode.

The technical solution of the present application is further described below:

in one embodiment, the pull cable is disposed between the proximal end of the stent and the valve assembly, and one end of the pull cable is connected to the stent and the other end of the pull cable is connected to the leaflet.

In one embodiment, the stent comprises a plurality of rods arranged at intervals and a connecting piece used for connecting with the conveying mechanism, and the proximal ends of the rods are connected to the connecting piece.

In one embodiment, the stent has a support section and a valve section connected to a distal end of the support section, the support section having a diameter larger than a diameter of the valve section, the support section for abutting against an inner wall of a bronchus, the valve assembly being disposed in the valve section.

In one embodiment, the bronchial valve further comprises a sealing membrane covering at least part of the circumference of the support section and at least part of the circumference of the valve section, the valve assembly being connected to the sealing membrane of the valve section.

In one embodiment, the free end edges of the leaflets are provided with folds that project towards the proximal end of the holder or towards the distal end of the holder, and the folds of adjacent leaflets abut each other when the valve assembly is in the closed state.

In one embodiment, the free end edges of the leaflets are provided with a skirt, and the skirt overlaps the adjacent leaflet when the valve assembly is in the closed state.

In one embodiment, a first connecting portion is provided on the bracket, a second connecting portion is provided on the leaflet, one end of the pulling cable is connected to the first connecting portion, and the other end of the pulling cable is connected to the second connecting portion.

In one embodiment, the first connecting portion is movably connected with the stent, and the state of the valve leaflet is adjusted through the position of the first connecting portion on the stent.

In one embodiment, the first connecting portion is provided with a first connecting hole, the second connecting portion is provided with a second connecting hole, one end of the stay is connected to the first connecting hole, and the other end of the stay is connected to the second connecting hole.

In one embodiment, the inhaul cable comprises a first wire element and a second wire element which are arranged side by side, one end of the first wire element and one end of the second wire element form a connecting ring together, the connecting ring is arranged in the second connecting hole in a penetrating mode, and the other end of the first wire element and the other end of the second wire element are connected with the limiting element after penetrating through the first connecting hole.

In one embodiment, the inhaul cable comprises a connecting section, one end of the connecting section is connected with a first ring portion, the other end of the connecting section is connected with a second ring portion, the first ring portion is used for being sleeved on the first connecting hole, and the second ring portion is used for being sleeved on the second connecting hole.

In one embodiment, the connecting section, the first ring portion and the second ring portion are integrally formed by bending.

In one embodiment, the plurality of pulling cables are provided, one ends of the plurality of pulling cables are connected to the bracket at intervals, and the other ends of the plurality of pulling cables are connected to the valve leaflet in a one-to-one correspondence manner.

Above-mentioned bronchus valve is through setting up valve assembly in the support, and when the outside gas flowed to obstructed lung lobe from the bronchus, a plurality of leaflet of valve assembly mutually supported make valve assembly form the closure state to connect support and leaflet through the cable, thereby prevent that the air current from blowing away the closure state with maintaining valve assembly with the leaflet is reverse, and then prevented that gas from getting into obstructed lung lobe. When residual gas or secretion in the lung lobes flows to the outside from the lung lobes, the plurality of valve leaflets of the valve assembly are separated from each other so that the bronchial valve enters an open state, thereby enabling the residual gas and secretion in the lung lobes to be naturally discharged. And the valve subassembly of bronchial valve of this application includes a plurality of leaflets, compares in traditional duckbill valve, and the valve subassembly that this application has a plurality of leaflets open the state under open the space bigger, more is favorable to the discharge of secretion. And the stay cable is connected with the support and the valve leaflet and can resist the airflow thrust in the direction from the near end to the far end of the support, so that the valve component is prevented from being pushed away by external airflow in the reverse direction in the closed state, and the air tightness of the valve component in the closed state is improved. Meanwhile, a necking structure is formed at the near end of the bracket, so that the bronchial valve is convenient to be put into the sheath, and the release and the recovery of the bronchial valve are facilitated.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention.

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic diagram of a bronchial valve in accordance with an embodiment;

FIG. 2 is a schematic view of the bronchial valve shown in FIG. 1 applied to a bronchus;

FIG. 3 is a schematic view of the bronchial valve shown in FIG. 1 in a closed state;

FIG. 4 is a schematic view of the bronchial valve shown in FIG. 1 in an open state;

FIG. 5 is a schematic view of a bracket according to an embodiment;

FIG. 6 is a schematic structural view of a valve assembly according to one embodiment;

FIG. 7 is a schematic structural view of another embodiment of a valve assembly;

FIG. 8 is a schematic structural view of a leaflet of the valve assembly shown in FIG. 7;

FIG. 9 is a schematic structural view of a cable according to an embodiment;

fig. 10 is a schematic view of the connection structure of the stay cable and the leaflet shown in fig. 9;

fig. 11 is a schematic view of the connection structure of the stay cable and the leaflet shown in fig. 10;

fig. 12 is a schematic structural view of a cable according to another embodiment.

Description of reference numerals:

10. a support; 11. a connecting member; 12. a rod member; 13. a support section; 14. a valve segment; 15. a first connection hole; 20. a valve assembly; 21. a leaflet; 22. a connecting portion; 23. folding edges; 24. a skirt edge; 30. a cable; 31. a first wire member; 32. a second wire member; 33. a connecting ring; 34. a limiting member; 35. a connecting portion; 36. a first ring portion; 37. a second ring portion; 40. a sealing film; 50. a bronchus; 60. the lobes of the lung.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

Specifically, the embodiment of the present application provides a bronchial valve, which is used for blocking the bronchial lumen and forming a one-way channel in the bronchus 50, thereby achieving the purpose of treating or improving emphysema diseases. Specifically, referring to fig. 1-4, a bronchial valve of an embodiment includes a stent 10, a valve assembly 20, and a pull cable 30. The stent 10 has a proximal end and a distal end, the proximal end of the stent 10 is the end relatively close to the operator during the operation, the distal end of the stent 10 is the end relatively far away from the operator during the operation, and a channel for air flow is formed along the direction from the distal end to the proximal end of the stent 10; in other embodiments, the proximal end of the stent 10 forms a necked configuration and the distal end of the stent 10 forms an open configuration. The stent 10 is used to abut against the wall of the bronchus 50 to support and fix the entire bronchial valve. The valve assembly 20 includes a plurality of valve leaflets 21, preferably, the plurality of valve leaflets 21 refers to three or more valve leaflets 21, in the embodiment, three valve leaflets 21 are provided, and it is understood that the number of valve leaflets 21 can be four, five or more. One end of each of the valve leaflets 21 is connected to the support 10, the other end of each of the valve leaflets 21 is a free end, the valve leaflets 21 are sequentially arranged adjacently, the valve assembly 20 has a closed state and an open state, the adjacent valve leaflets 21 abut against each other to block the channel in the closed state, the adjacent valve leaflets 21 are separated to open the channel in the open state, the stay cable 30 is connected with the valve assembly 20, and the stay cable 30 is used for controlling the state or position of the valve leaflets 21 to enable the channel of the support 10 to be in a one-way opening structure. The bracing wires 30 in this embodiment are used to control the free end position of the leaflets 21, thereby changing the state of the valve assembly 20. Specifically, the pulling cable 30 is disposed between the proximal end of the stent 10 and the valve assembly 20, one end of the pulling cable 30 is connected to the stent 10, the other end of the pulling cable 30 is connected to the valve leaflet 21, the pulling cable 30 is used for resisting the pushing force of the airflow in the direction from the proximal end to the distal end of the stent 10 so as to maintain the closed state of the valve assembly 20, thereby preventing the outside airflow from flowing into the lung from the direction from the proximal end to the distal end of the stent 10, and when the residual airflow in the lung flows out from the direction from the distal end to the inlet end of the stent 10, the valve leaflet 21 is opened, thereby conducting the passage of the stent, and thus realizing the unidirectional opening of the passage of the stent 10.

Further, referring to fig. 1 and 2, the proximal end of the stent 10 is used to connect a delivery mechanism, which is used to deliver and release the bronchial valve to a desired location through a sheath during a surgical procedure. During delivery, the bronchial valve is compressed within the sheath, expands back to the pre-shaped shape due to shape memory when the bronchial valve is delivered to the pre-determined location and released from the sheath, and the distal end of the bronchial valve is now facing the lung lobes 60. When the bronchial valve is completely unfolded, the bronchial valve can block the bronchial cavity, so that the bronchial cavity forms a one-way channel.

Specifically, referring to fig. 3, when the external air flows from the bronchus 50 to the blocked lung lobes 60, the plurality of valve leaflets 21 of the valve assembly 20 abut against each other to form the valve assembly 20 into the closed state, thereby preventing the air from entering the blocked lung lobes 60, and at this time, the pulling cable 30 is straightened to resist the pushing force of the air flow on the valve assembly 20, preventing the valve assembly 20 from being blown open reversely, thereby maintaining the closed state of the valve assembly 20. Referring to fig. 4, when the residual gas or secretion in the lung lobe 60 flows from the lung lobe 60 to the outside, the plurality of valve leaflets 21 of the valve assembly 20 are pushed away by the thrust of the gas flow or secretion, and the free ends of the valve leaflets 21 move towards the proximal end of the stent 10, the pulling cable 30 bends or displaces, so that the bronchial valve enters the open state, and the bronchial valve forms a channel for naturally discharging the residual gas and secretion in the lung lobe 60.

The above-mentioned bronchus valve is through setting up the valve assembly 20 in the support 10, when the external air flows to the lung lobe 60 blocked from the bronchus 50, the valve assembly 20 that a plurality of valve leaflets 21 of the valve assembly 20 abut each other makes the closed state of the valve assembly 20, and through setting up the guy cable 30 between proximal end of the support 10 and valve assembly 20, make guy cable 30 connect support 10 and valve leaflet 21, thus prevent the air current from blowing the valve leaflet 21 away in reverse to maintain the closed state of the valve assembly 20, and then prevent the air from entering the lung lobe 60 blocked. When the residual gas or secretions in the lung lobes 60 flow from the lung lobes 60 to the outside, the plurality of valve leaflets 21 of the valve assembly 20 are separated from each other to bring the bronchial valve into an open state, thereby allowing the residual gas and secretions in the lung lobes 60 to be naturally discharged. And the valve assembly 20 of the bronchial valve of the present application comprises a plurality of valve leaflets 21, compared to the conventional duckbill valve, the valve assembly 20 of the present application having a plurality of valve leaflets 21 has a larger opening space in the open state, which is more favorable for the discharge of secretions. The support 10 and the valve leaflet 21 are connected through the pull cable 30, the pull cable 30 can resist the airflow thrust in the direction from the proximal end to the distal end of the support 10, the valve assembly 20 is prevented from being pushed away by the external airflow in the reverse direction in the closed state, and the air tightness of the valve assembly 20 in the closed state is improved. Meanwhile, the proximal end of the bracket 10 forms a necking structure, so that the bronchial valve is convenient to retract into the sheath, and the release and recovery of the bronchial valve are facilitated.

Referring to fig. 1 and 5, further, the stent 10 includes a plurality of rods 12 and a connecting member 11, the rods 12 are arranged at intervals, and the proximal ends of the rods 12 are connected to the connecting member 11 to form a constricted structure. The connecting element 11 is used for connecting with a conveying mechanism. Preferably, the connector 11 is used to connect a push wire cable of a delivery system for pushing the bronchial valve out of the sheath to release the bronchial valve, or for pulling the bronchial valve into the sheath to retrieve the bronchial valve. Further, the connection means of the connecting member 11 and the conveying mechanism is not limited to a threaded connection, a clamping connection, other mechanical connection or non-mechanical connection. Preferably, the number of the rods 12 of the stent 10 can be selected as desired, and preferably, the number of the rods 12 is 8 to 12. Through all being connected to the proximal end of all member bars 12 of support 10 and forming the throat structure on connecting piece 11, when retrieving the bronchial valve into the sheath pipe, connecting piece 11 can play the guide effect to compress gradually the bronchial valve from the proximal end to the distal end and retrieve in the sheath pipe, and then be convenient for bronchial valve to go into sheath and retrieve and secondary release.

Further, the stent 10 has a support section 13 and a valve section 14 connected to a distal end of the support section 13, the support section 13 having a diameter larger than that of the valve section 14, the support section 13 being adapted to abut against an inner wall of the bronchus 50, and the valve assembly 20 being disposed on the valve section 14. Through the diameter that makes support section 13 be greater than valve section 14, thereby can guarantee support section 13 and the position of the inner wall butt that connects bronchus 50 in order to anchor bronchus valve in bronchus 50 after the release bronchus valve, and valve section 14 has certain clearance with bronchus 50's inner wall, thereby avoid valve assembly 20 on the valve section 14 and bronchus 50's inner wall direct contact, and then avoided bronchus 50 inner wall mucociliary motion or granulomatous hyperplasia and influence the normal switching function of bronchus valve. Further, one end of the pulling cable 30 is connected to the support section 13, and the other end of the pulling cable 30 is connected to the leaflet 21, so that the free end of the leaflet 21 can only open towards the proximal direction of the stent 10, while the movement of the free end of the leaflet 21 towards the distal direction of the stent 10 is limited by the pulling cable 30, thereby ensuring the one-way conduction function of the valve assembly 20.

Further, with continued reference to fig. 5, the bronchial valve further comprises a sealing membrane 40, the sealing membrane 40 covering at least part of the outer circumference of the support section 13 and at least part of the outer circumference of the valve section 14, the valve assembly 20 being connected with the sealing membrane 40 of the valve section 14. Preferably, the valve assembly 20 and the sealing membrane 40 are sealingly connected by bonding, sewing, etc., and are not limited to being integrally formed. For example, in this embodiment, the sealing membrane 40 covers a portion of the outer circumference of the strut section 13 near the distal end and a portion of the outer circumference of the valve section 14 near the proximal end. Wherein the sealing film 40 on the supporting section 13 is used for tightly fitting with the inner wall of the bronchus 50, thereby preventing the air flow from passing through the gap between the supporting section 13 and the inner wall of the bronchus 50. While the sealing membrane 40 on the valve section 14 is intended to fit snugly against the valve assembly 20, thereby preventing airflow from passing through the gap between the valve section 14 and the valve assembly 20. Preferably, the material of the sealing film 40 may be silicone, polyurethane, or the like; the sealing film 40 can be formed and fixed on the support 10 by leaching, injection molding, spraying and the like. It is of course also possible to form the sealing film 40 separately and then to adhere it to the carrier 10. Further, the thickness of the sealing film 40 is preferably 50 to 200 μm.

Referring to fig. 6, the free end edge of the leaflet 21 is provided with a folded edge 23 protruding towards the proximal end of the support 10 or towards the distal end of the support 10, specifically, the free end edge of the leaflet 21 includes a first edge and a second edge forming an included angle, and the first edge and the second edge are both provided with the folded edge 23. And the folds 23 of adjacent leaflets 21 abut each other when the valve assembly 20 is in the closed state. In the closed state, the two adjacent valve leaflets 21 abut against each other through the folded edges 23, so that the contact area of the two adjacent valve leaflets 21 is increased, and the air tightness of the valve assembly 20 in the closed state is further improved. Preferably, the raised height of hem 23 is 1mm to 2 mm.

Referring to fig. 7 and 8, in another embodiment, the free end edge of the leaflet 21 is provided with a skirt 24, preferably, the free end edge of the leaflet 21 includes a first edge and a second edge that are angled, and the skirt is provided on the first edge or the second edge. The skirt 24 overlaps the adjacent leaflets 21 when the valve assembly 20 is in the closed position. For example, in the present embodiment, the first edge of each leaflet 21 is provided with a skirt 24, when the valve assembly 20 is in the closed state, the skirt 24 covers the second edge of the adjacent leaflet 21, and by overlapping the skirt 24 with the adjacent leaflet 21, the contact area between the two adjacent leaflets 21 is increased, thereby improving the air tightness of the valve assembly 20 in the closed state. Preferably, the skirt 24 and the valve leaflet 21 are integrally formed, or the skirt 24 is separately formed and then sewn or adhered to the side edge of the valve leaflet 21. Further, the skirt 24 has a thickness of 20 to 50 micrometers. Further, the central angle θ of the sector where the skirt 24 overlaps the adjacent leaflet 21 is 10 ° to 30 °.

Further, the material of the leaflet 21 may be silica gel, polyurethane, or the like. Preferably, the thickness of the leaflet 21 is 50 to 200 μm, and the length of the portion of the leaflet 21 connected to the stent 10 is 3 to 5 mm.

Further, be equipped with first connecting portion on the support 20, be equipped with the second connecting portion on the leaflet 21, the one end of cable 30 is connected to first connecting portion, and the other end of cable 30 is connected to the second connecting portion to it is firm to realize that cable 30 and support 20 and leaflet 21 are connected. Further, in one embodiment, the first connecting portion is movably connected to the stent 20, and the state of the leaflet 21 is adjusted by the position of the movable connection. For example, the first connection portion is slidably connected to the stent 20, i.e., a first connection position relatively far away from the proximal end of the stent 20 and a second connection position relatively close to the proximal end of the stent 20 can be formed therebetween, when the external air flows from the bronchus 50 to the blocked lung lobes 60, the first connection portion is located at the first connection position, the plurality of valve leaflets 21 of the valve assembly 20 abut against each other to form the valve assembly 20 into a closed state, so as to prevent the air from entering the blocked lung lobes 60, and at this time, the pulling cable 30 is straightened to resist the pushing force of the air flow on the valve assembly 20, so as to prevent the valve assembly 20 from being blown back, thereby maintaining the closed state of the valve assembly 20. When the residual gas or secretion in the lung 60 flows to the outside from the lung 60, the first connection portion moves from the first connection position to the proximal direction of the stent 20 to the second connection position, so that the pull cable 30 drives the free ends of the valve leaflets 21 to move towards the proximal direction of the stent 10, the free ends of all the valve leaflets 21 are separated from each other, the valve assembly enters the open state, and the bronchial valve forms a channel which can naturally discharge the residual gas and secretion in the lung 60.

Further, in one embodiment, the first connection portion is provided with a first connection hole 15, the second connection portion is provided with a second connection hole, one end of the stay 30 is connected to the first connection hole 15, and the other end of the stay 30 is connected to the second connection hole.

Further, referring to fig. 9 to 11, the cable 30 includes a first wire 31 and a second wire 32 arranged side by side, one end of the first wire 31 and one end of the second wire 32 together form a connection ring 33, the connection ring 33 is inserted into the second connection hole, the other end of the first wire 31 and the other end of the second wire 32 both pass through the first connection hole 15 and then are connected to a limiting member 34, and the limiting member 34 is used for preventing the first wire 31 and the second wire 32 from coming out of the first connection hole 15.

Specifically, in one embodiment, when manufacturing the cable 30, a single nitinol wire may be folded in half, and then the connecting ring 33 may be bent out of the end of the folded nitinol wire by using a mold, so as to form the first wire 31, the second wire 32, and the connecting ring 33 connected between the first wire 31 and the second wire 32. Then, after the lengths of the first wire 31 and the second wire 32 are sufficiently reserved, the filaments are set in a heat setting furnace at 500 to 550 ℃ for 5 to 15 minutes. At this time, the end of the first wire 31 and the end of the second wire 32 far from the connection ring 33 are not connected with the limiting member 34, so that an opening communicating with the connection ring 33 is formed between the first wire 31 and the second wire 32, the first wire 31 or the second wire 32 can pass through the second connection hole by using the opening, and finally the connection ring 33 is sleeved in the second connection hole, and then the first wire 31 and the second wire 32 both pass through the first connection hole 15 and are trimmed to a suitable length, the limiting member 34 is used to connect the first wire 31 and the second wire 32, and the limiting member 34 and the first wire 31 or the second wire 32 are fixed by welding or bonding, preferably, the limiting member 34 is a spherical structure, the limiting member 34 is provided with a third connection hole, after the first wire 31 and the second wire 32 pass through the first connection hole 15 and are trimmed to a suitable length, the first wire 31 and the second wire 32 are passed through the third connection hole and then are fixed by laser welding, thereby realizing the fixation of the first wire 31, the second wire 32 and the limiting member 34. Further, the diameter of the retaining member 34 is slightly larger than that of the first connection hole 15, so as to prevent the first wire 31 and the second wire 32 from coming out of the first connection hole 15.

Referring to fig. 12, in another embodiment, the cable 30 includes a connecting section, one end of the connecting section is connected with a first ring portion 36, the other end of the connecting section is connected with a second ring portion 37, the first ring portion 36 is configured to be sleeved on the first connecting hole 15, and the second ring portion 37 is configured to be sleeved on the second connecting hole. Preferably, the connecting section, the first ring 36 and the second ring 37 are integrally formed by bending a single metal wire, so that the cable 30 has a simpler structure.

Further, there are a plurality of the pulling cables 30, one ends of the plurality of pulling cables 30 are connected to the stent 10 at intervals, and the other ends of the plurality of pulling cables 30 are connected to the leaflet 21 in a one-to-one correspondence. For example, in the present embodiment, the valve assembly 20 includes three valve leaflets 21, and correspondingly, the number of the guy cables 30 is three, one end of each of the three guy cables 30 is connected to the support 10 at intervals, and the other end of each of the three guy cables 30 is connected to the corresponding valve leaflet 21 in a one-to-one correspondence manner, so as to ensure that each valve leaflet 21 has the corresponding guy cable 30 connected thereto, and further prevent the valve leaflet 21 from being blown away by the airflow in the opposite direction.

Further, the material of the stay 30 may be nitinol. The diameter of the pull string 30 should not be too large to affect the proper opening and closing of the valve assembly 20. Preferably, the diameter of the cable 30 is 0.003 to 0.006 feet. Further, the length of the guy cable 30 should not be too long or too short, and the valve assembly 20 should be smoothly opened and closed, and the valve assembly 20 is just straightened when in the closed state, so that the problem that the guy cable 30 cannot prevent the valve leaflet 21 from being blown away reversely due to the too long guy cable 30 is avoided, and the problem that the valve assembly 20 is normally closed due to the too short guy cable 30 is also avoided.

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.

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

In the above description of the specific embodiments, "proximal" refers to the end of the bronchial valve that is relatively close to the operator during surgery, and "distal" refers to the end of the bronchial valve that is relatively close to the operator during surgery.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

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

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.