CN110742667A

CN110742667A - Methods and devices for treating pulmonary dysfunction using implantable valves

Info

Publication number: CN110742667A
Application number: CN201811213823.7A
Authority: CN
Inventors: 托滕·肖恩; 李·杰森; 刘·利立普; 田中·唐; 盖尔芬德·马克
Original assignee: Suzhou Yourui Medical Technology Co Ltd
Current assignee: Suzhou Yourui Medical Technology Co Ltd
Priority date: 2018-07-23
Filing date: 2018-10-18
Publication date: 2020-02-04

Abstract

A flow control valve device implantable in a bronchial passage for treating lung dysfunction, the flow control device (241, 260, 300, 350, 450, 480, 500) comprising: a one-way valve (273, 313, 360, 478, 511); a hollow structural frame (242, 302, 352, 453, 468, 509) containing the one-way valve, wherein said structural frame is expandable from a compressed state to a deployed state, and a sealing membrane (316, 470, 512) mounted at least at a distal end of the structural frame, wherein said sealing membrane may form at least a part of the inner wall of the flow control device, and the one-way valve may be contained in the airflow channel.

Description

Methods and devices for treating pulmonary dysfunction using implantable valves

Technical Field

The present invention generally describes a lung volume reduction device for treating patients with lung hyperinflation, such as patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD), emphysema, asthma, bronchitis. The present invention relates to lung volume reduction devices, such as deployable valves, that can be delivered from the respiratory tract into the lungs by a minimally invasive interventional technique.

Background

Pulmonary hyperinflation is a respiratory distress lung disease that is the leading cause of disability, and COPD can be ranked as the third leading cause of death in the united states. The symptoms and effects of COPD can worsen over time, for example in the next few years, and can limit the ability of the patient to perform daily activities. Current medical technology has not been able to reverse the airway and lung lesions associated with COPD.

In general, COPD does not consistently affect all of the air sacs or alveoli in the interior of the lungs. Diseased areas may exist in the lungs where the air sacs are damaged and no longer possess proper ventilation function. There may also be healthy areas in the same lung that are not diseased (or at least relatively healthy areas) where the balloon can continue to function effectively for ventilation. The affected area may account for twenty to thirty percent, or more, of the total lung space.

Diseased areas in the lungs may occupy a portion of the respiratory space that would otherwise be occupied by healthy areas. If healthy areas in the lung can be expanded to the space occupied by the affected area, these healthy areas can be expanded and inflated, thereby allowing the balloon in the healthy areas to exchange oxygen and carbon dioxide gas.

The method and apparatus described in patent US2014/0058433 may be used to regulate fluid flow to and from a region in a patient's lung, for example to achieve a desired fluid flow to a lung region during breathing, and/or may be used to collapse one or more lung regions. According to one exemplary process, an identified region in the lung may be the target of treatment. Such a target lung region is then isolated at its bronchi, and the flow of air into and/or out of the target lung region is regulated by one or more bronchial passages that deliver air to the target lung region.

US7842061 discloses an endotracheal device which can be placed and fixed in a certain respiratory tract of a patient to collapse a certain lung region and its associated respiratory tract. The device includes a support structure, a sealing element carried by the support structure that reduces ventilation of the lung region by preventing air from being drawn into the lung region, and at least one hook anchor carried by the support structure to secure the sealing device within the airway. The hook anchor may engage the airway passage by puncturing or friction, and includes a stop-stop structure of suitable size to limit puncturing of the airway passage and to release from the airway passage for removal of the endobronchial device. The hook anchor may be carried by a peripheral or central portion on the support structure. The sealing element may be a one-way valve.

Patent WO2004010845 discloses a bronchial respiratory tract flow control device. The device includes a valve element operable to regulate fluid flow through the flow device, a frame coupled to the valve element, and a membrane attached to the frame. At least a portion of the flow control device may form a seal with an inner wall of the airway when the flow control device is implanted in the airway. The membrane may form a fluid pathway from the seal into the valve element to direct fluid flow through the bronchial airways into the valve element.

However, there remains a need for a lung volume reduction device and procedure that can effectively, and economically, quickly implantable, easily evaluated, removably, and safely treat patients with lung hyperinflation.

Disclosure of Invention

The present invention relates to a method, device and system for lung volume reduction in patients with lung hyperinflation, such as COPD.

One aspect of the present invention relates to a device for reducing the volume of a diseased lung lobe of a patient, comprising a proximal end, a deployable frame, a sealing element, a valve, and a fixation element. The device may be an endobronchial valve, such as a one-way valve. These functions may be performed by different structures, or in some embodiments, one or more of these functions may be performed by one or more structures.

The structural frame of the endobronchial valve may be made from a laser cut nitinol tube and contain straight, helical or complementarily arranged support strips and connected at each end to a tubular structural section. Such a nitinol tube may be of superelastic nitinol material having an Outer Diameter (OD) of 0.083 inches (2.1 millimeters) and an Inner Diameter (ID) of 0.072 inches (1.8 millimeters). The deployable structure is deployable from a compressed configuration to an expanded configuration and has a ratio of diameter in the expanded configuration to diameter in the compressed configuration in the range of 3 to 6 (e.g., 5 to 6). The nitinol frame structure may be preformed such that the struts may have radially-expanding proximal and distal portions connected by a central section parallel to the axis of the device. The length of such a central section may be in the range of 0.13 to 0.19 inches (3.3 to 4.8 millimeters). The structural frame may be made of a biodegradable material.

At the proximal end of the structural frame, a gripping element may be included. The gripping element may be adapted to interact with a delivery tool and may transmit rotational and translational forces from the delivery tool to the device.

The endobronchial valve, for example a one-way valve, may comprise a sealing element, which may be a flexible membrane connected to the structural frame.

The endobronchial valve may include a one-way valve that allows air to pass from its distal end to its proximal end.

Also disclosed herein is a method of treating a patient with COPD, comprising delivering a leaflet valve through a working channel of a bronchoscope and placing the leaflet valve in a leaflet bronchus leading to a diseased region in a lung, whereby the leaflet valve can allow air to be released from the diseased lung and can prevent air from entering the diseased lung. The method may further comprise attaching a fixation element on the leaflet valve to the carina distal to the bronchi of the leaflet. The fixation element may be a carina bolt or a carina clip. The valve may be positioned in the lobar bronchus, and a central axis of the valve may be non-parallel to a central axis of the lobar bronchus.

Drawings

FIG. 1 is a schematic representation of the lungs and respiratory tract of a patient with the right middle lobe of the lung omitted.

Fig. 2 is a conceptual diagram of a structural framework.

Fig. 3A is a conceptual diagram of a pulmonary lobe valve.

Fig. 3B is a conceptual diagram of another leaflet valve.

Fig. 4A is a conceptual schematic view of another leaflet valve.

Fig. 4B is a conceptual diagram of another leaflet valve.

Fig. 4C is a conceptual schematic view of another leaflet valve.

Figure 4D is a cross-sectional schematic view of the leaflet valve shown in figure 4C.

Fig. 5A is a conceptual schematic view of another leaflet valve.

Figure 5B is a side view of the leaflet valve shown in figure 5A.

Figure 5C is a schematic cross-sectional view of the leaflet valve shown in figure 5A.

Fig. 6A is a schematic view of a delivery tool delivering a valve device through a bronchoscopic working channel.

Fig. 6B illustrates a delivery tool holding an implantable valve in a collapsed state in a delivery sheath.

Fig. 6C illustrates a delivery tool advancing an implantable valve through a delivery cannula.

Fig. 6D and 6E are schematic diagrams of other delivery tool concepts.

Figure 6F illustrates a delivery tool advancing an implantable valve through a delivery cannula with a forceps-like tool grasping a carina of an airway bifurcation.

Fig. 7A illustrates a delivery sheath tube containing the leaflet valve connected to the delivery tool, with the remainder of the leaflet valve having been extended from the delivery sheath in a deployed, unconstrained state.

Figure 7B illustrates a leaflet valve contained within a delivery cannula attached to a delivery rod, the delivery cannula being advanced through a bronchoscopic working channel disposed within a target leaflet bronchus.

Figure 7C illustrates a leaflet valve contained within a delivery sheath coupled to a delivery rod and having been partially delivered from the delivery sheath (stage 1), the delivery sheath being advanced through a bronchoscope working channel placed within a target leaflet bronchus.

Fig. 7D shows the leaflet valve fully delivered from the delivery cannula (stage 2), and has been released from the delivery rod and placed in the target leaflet bronchus.

Detailed Description

The present invention disclosed herein relates to systems, devices and methods for modifying the flow of air to and from a region of a patient's lung using an implantable device to reduce the volume of air trapped in the target region of the lung, thereby enhancing the recoil characteristics of the remaining lung volume, which can be used in severe patients.

The authors of the present invention have contemplated and published herein implantable lung volume reduction devices, and medical techniques for implanting lung volume reduction devices through the trachea and bronchi using minimally invasive deployment methods, bronchoscopes, and surgical techniques. The device may be an endobronchial valve, such as a one-way lung leaflet valve.

The present invention may be an embodiment for providing an innovative therapy for patients with pulmonary hyperinflation (e.g., emphysema, COPD, bronchitis, asthma) comprising implanting a lung volume reduction device into the airways in the lungs of the patient using a minimally invasive bronchoscopic technique. The implantable lung volume reduction devices disclosed herein, which may be generally referred to as "lobe valves," may be placed in the dry airways of the lobes of the lungs, such that the single valve may regulate airflow to and from the entire lobe, and may possess the benefits previously associated with the multi-valve placement trial valves used in advanced airways. Benefits from a lobe valve may include low cost, rapid procedure, ease of implantation, ease of removal, and more stable fixation. However, the features of the devices disclosed herein may be innovative and may be used in higher respiratory tracts and are not limited to devices that may be placed within the main trunk of the lung lobes.

Anatomy, design content and challenges:

fig. 1 is a schematic representation of certain anatomical features of the lungs. Air may pass through air tube 41, with air tube 41 branching 42 into left and right

main air tubes

43 and 60. The lungs are usually distinct, anatomical partitions called lobes of the lungs. The right lung 55 is divided into three lobes, referred to as the superior lobe 45, the middle lobe (not shown for simplicity), and the inferior lobe 47, by a diagonal seam 57 and a flat seam 58 that the visceral pleura folds into. The left lung 56 is relatively small and is divided into superior lobe 51 and inferior lobe 53 by an oblique slot 59. The term "proximal direction" refers to a direction along a respiratory path, toward the mouth or nose of a patient, and away from the lungs of the patient. In other words, the proximal direction is generally the same as the exhalation direction during the patient's breathing. The term "proximal portion" or "proximal end" in reference to implantation into an internal respiratory device of a patient refers to the portion or end of the device that faces in a proximal direction. The term "distal direction" refers to a direction along a respiratory path, toward the lungs of a patient, and away from the mouth or nose. The distal direction is generally the same as the direction of inspiration during the patient's breathing. The term "distal portion" or "distal tip" in reference to implantation within the respiratory tract of a patient refers to the portion or tip of the device that faces in a distal direction.

The

lobar valves

241, 300, 260, 350, 450, 480, 500 can be implanted in the secondary bronchi, also known as lobar bronchi. Each lobe of the human has a lobe bronchus for delivering air, including three in the right lung and two in the left lung. The right lobar bronchus includes a right superior lobar bronchus 44, a right middle lobar bronchus (not shown for simplicity), and a right inferior lobar bronchus 46. The left lobar bronchi include left superior lobal bronchi 50 and left inferior lobal bronchi 52. Overlapping end plates in the lobar bronchi may provide structural support to maintain patency of these bronchi. The human lobar bronchi have an average diameter of about 8.3 mm and an average length of 19 mm (e.g., in the range of 15 to 30 mm).

The disclosed lung leaflet valve embodiment designs allow for delivery, ease of use, and cost.

The valve may be delivered through the working channel of a bronchoscope. The leaflet valve and delivery tool are sized to freely navigate through the working channel of the bronchoscope. For example, a leaflet valve that can be delivered through a working lumen having a diameter of 2.8 mm may have a maximum diameter of 2.6 mm (e.g., the maximum diameter may be 2.5,2.4,2.3,2.2,2.1 mm). In some embodiments, the leaflet valve may include a structural frame having a delivery state and a deployed state, wherein the delivery state has a maximum diameter in the range of 2(0.0787) to 2.5 mm (0.0984 inches), preferably 2.11 mm (0.083 inches), and an unconstrained deployment state has a maximum diameter in the range of 10.16(0.4) to 14 mm (0.551 inches), preferably 12.42 mm (0.489 inches), for placement in a leaflet bronchus having an average diameter in the range of 7 to 12 mm. For example, the ratio of the maximum outer diameter in the unconstrained state to the maximum outer diameter in the bunched delivery state may be in the range of 4:1 to 7:1, e.g., 5.45: 1. Due to the relatively larger diameter and shorter length of the lobar bronchi, the lobar valve in its expanded unconstrained state can have a smaller aspect ratio than current devices and thus can be placed at more distal locations. For example, a leaflet valve may have a length in its unconstrained state in the range of 4 to 6 millimeters, and a slenderness ratio in the range of 0.545 to 0.286. The valve leaflets can be of various sizes for use in different diameter airways, and typically have a structural framework with a maximum diameter in the unconstrained deployment of 5% to 30% (e.g., about 20%) greater than the diameter of the target airway. However, the implantable valve design features disclosed herein can be widely adapted for use in various morphologic airways, including different diameters (e.g., 7 to 12 millimeters), lengths (e.g., 5 to 15 millimeters), and geometries (e.g., circular, elliptical, or irregular shapes), which can improve delivery rates and simplify the delivery process. The target airway may be measured using CT or other medical imaging techniques or a bronchoscopically delivered measurement device. A membrane may be attached to the structural frame to effect the function of an airway seal or an airflow control valve. The maximum diameter of the structural frame and the film attached thereto in the as-transported state may be less than 2.7 mm (e.g. less than 2.6,2.5,2.4,2.3,2.2,2.1 mm), with a maximum diameter of about 2.3 mm being preferred. Other alternative embodiments of the leaflet valve may have different sizes, allowing it to be delivered in bronchoscopes with different sized working channels. Alternatively, the leaflet valve may have a non-circular cross-section (e.g., oval, elliptical, irregular) in an unconstrained state, which may be more suitable for use in a bronchus having a non-circular cross-section. Alternatively, the valve itself may conform to a non-circular cross-section of the bronchial or irregularly shaped airway wall surface.

An easy to use and convenient procedure is an ideal requirement. The leaflet valve can be designed to be consistently delivered to the correct location by the average physician skill. The lobe valve can be implanted more quickly than a valve implanted in a higher respiratory tract, since only one valve needs to be implanted to affect this entire lobe, and the lobe bronchi are larger and more proximal and therefore easier to find and intervene than the higher bronchi. In addition, it may be simpler and faster to assess the efficacy of one implanted lung leaflet valve than to assess multiple distally implanted valves.

A leaflet valve and the procedure for implanting it can be less expensive than implanting multiple superior valves, especially if only one device needs to be implanted and the procedure for implanting it is faster.

Design considerations may also relate to particular challenges associated with placement in a lobar bronchus. For example, the lobar bronchi are relatively short in length, have a relatively small ratio of length to diameter, are radially asymmetric (e.g., elliptical or irregular) in cross-section, and have lumens with diameters that are not uniform in length (e.g., flared at the proximal end, or at the distal end, or both). Further, each lobar bronchus of the patient has unique characteristics, such as progressive angulation and geometry.

The leaflet valve may include a structural frame deployable from a contracted delivery state to an expanded configuration, a sealing element, a one-way valve, and a fixation element. These constituent elements may be mixed and matched, and the embodiments are not limited to the combinations of the elements shown in the drawings.

Structural framework:

the leaflet valve 241 comprises a deployable structural frame 242 that can be made from a laser cut round tube, such as from a biocompatible metal, such as superelastic nitinol (e.g., a tube having an outer diameter of 0.083 inches and an inner diameter of 0.072 inches, a tube having an outer diameter in the range of 0.07 to 0.085 inches and a tube wall thickness in the range of 0.005 to 0.015 inches). A structural frame 242 may comprise a series of interconnected support bars that provide some flexibility to the frame, allowing it to be deployed from a collapsed delivery state to an expanded deployed state, and may provide support for sealing membranes, valves, and fixation elements. In its bunched delivery state, the diameter of the structural frame is approximately the diameter of the laser cut tube used to make the structural frame. A structural frame of nitinol may be laser cut from a tube material and may be shaped in its unconstrained, expanded state. Another method of manufacture may include a structural frame made from shaped nitinol wires. A frame made of shaped nitinol or other shape memory material is capable of elastically deforming in the direction of its unconstrained expanded state when subjected to an external force within a target airway, particularly an airway having a diameter less than the diameter of the frame after it has been fully expanded. For example, the diameter of the frame in the fully expanded state may be 5% to 80% larger (e.g., about 10% band 30%) than the diameter of the target airway. This elastic nature also allows the device to be collapsed into a delivery configuration when loaded and contained within a delivery cannula and deployed into a deployed configuration when advanced out of the delivery cannula. The tube may have a proximal end and a distal end, wherein the proximal end may comprise a coupling element to mate with a delivery device and may have a notch such that the gripping element may transmit rotational and translational forces from the delivery tool to the structural frame. The coupling element may be provided as a graspable projection structure that may be grasped with a bronchoscope tool to manipulate the device as it is implanted, adjusted, or removed.

In one formulation, the maximum diameter of the leaflet valve in an unconstrained deployment state is 12 mm (0.472 inches), which is suitable for placement in airways having diameters in the range of 6 to 10 mm (0.236 to 0.394 inches) and can provide effective sealing, while larger size valves having a maximum diameter of 14 mm (0.551 inches) are suitable for placement in airways having diameters in the range of 7 to 12 mm (0.276 to 0.472 inches) and can provide effective sealing. Further, after placement, the structural frame may expand and contract with movement of the bronchus (e.g., upon elastic retraction). The shape of the structural frame, or the use of its fixation elements, may resist tilting effects, or may function properly when placed at an angle to the bronchial axis. In addition, the structural frame may be compressed after it is fully deployed to facilitate repositioning. For example, a delivery tool may be used to grasp or couple onto the coupling elements of the frame and draw them into the delivery cannula to compress the structural frame.

In a collapsed delivery state of the device, such as shown in fig. 7B, a structural frame 509, including its interconnecting struts 510, spokes 501, valve cover 505, and coupling elements 502, is sufficiently flexible to pass through its lumen 194 when an endoscope 196 (e.g., a bronchoscope) is bent through a tortuous airway (e.g., a bend radius as small as 15 millimeters).

Alternatively or additionally, the structural framework may be made of a bioabsorbable material, such as a laser cut high polymer (e.g., PLA, PLAGA, PDLLA) tube.

Alternatively or additionally, the structural frame may be an expandable balloon, or made of a plastically deformable material, such as plastic, cobalt-chromium alloy, martensitic nitinol, stainless steel, silicone or polyurethane.

Alternatively or additionally, the structural framework may be impregnated with an antifungal, antibacterial, anti-schizolytic, or anti-inflammatory agent to improve the patient's response to the implanted device.

Alternatively, the coupling elements may be laser cut on the same tube from which the structural frame is made, or attached (e.g., welded, stranded) to the structural frame. The delivery/removal tool may be a specially designed device to mate with and apply rotational and translational forces to the valve. Alternatively, the delivery/removal tool may be a conventional pincer catheter adapted for use within a bronchoscope working channel.

In some embodiments of a leaflet valve, such as shown in fig. 2, 3A, 3B, 4A, 4B, 4C, and 5A, the structural frame may include support bars that are interconnected to form an expandable wall-contacting

region

248, 309, 454, wherein the wall-contacting region is connected at a proximal end to spokes 247, 307, 356 that are connected to a valve cover and coupling element 245, 304, 356.

In these embodiments, such wall contact regions may conform to the lobar bronchi of elliptical or irregular shaped cross-section; the device can conform to irregular respiratory surfaces and can seal against surfaces with bumps, folds, grooves or other irregularities; the overall length of the device may be a length suitable for placement into the lobar bronchi; the valve can be easily expectorated out of the body after being detached from the implantation site; the device may also be adapted for implantation into the bronchi of the lobes of the lungs in a wider range of sizes and shapes.

Wall contact area

As shown in the example of FIG. 3A, an implantable valve 300 in its unconstrained expanded state includes a wall-contacting region 309 toward a distal end portion 303 of the device 300, which is comprised of a structural frame 302 and a sealing membrane 312 attached thereto. The wall-contacting region resembles a cylinder, can be pressure-fitted to the inner wall of a target airway (e.g., a lobar bronchus), restricts or impedes airflow between the wall-contacting region and the airway wall, and can contain a one-way valve 313 within the lumen of the airway, thereby greatly restricting the flow of air through the airway from all passing through the valve. The wall contact region 309 may generate an outward contact force and friction with the airway to help resist longitudinal displacement within the airway so that it may reside at the implant site. The wall contact region 309 can be flexible or elastic to conform to the airway in the cylindrical shape of the lung (e.g., irregular, elliptical, conical, flared) or non-compliant (convex, corrugated, wavy), or can apply a greater contact force to deform the airway wall, or by a combination of both, to form a continuous annular sealing band to prevent air leakage into the target area within the lung under normal intra-pulmonary air pressure differentials. When the device is implanted in a target airway, the structural frame can exert a contact force outward that can expand the airway wall by no more than 20%, which can create a strong enough contact and achieve the desired airtight effect while avoiding damage to the tissue that would otherwise create excess granulation tissue. The wall contact area may include circumferentially extending support strips 308 that may press the membrane 312 against the airway wall, preventing the membrane from forming air paths due to longitudinal folds that may leak air. For example, the interconnecting struts 308 may apply a continuous circumferential contact pressure (including a zig-zag direction, a diagonal direction, a spiral direction, or a diamond arrangement) to the airway wall. The interconnecting struts may cooperate with the sealing membrane to apply a contact pressure and may provide an interface between the wall contact area and the airway wall. In some cases, the sealing membrane may form folds or folds during implantation of the valve in the respiratory tract, such as may result from the irregular shape of the respiratory tract. This circumferentially continuous arrangement of interconnecting support strips prevents wrinkling or folding of the membrane and thus assists in the gas-tight action.

Alternatively, a wall contact region 309 in its unconstrained state may be barrel-shaped (e.g., the middle portion being slightly wider than the proximal and distal portions) or flared (e.g., the distal portion having a larger diameter than the proximal portion), which may aid in forming a good contact area and seal with the airway wall.

The wall contact areas 309 of the structural frame 302 may provide a support for the membrane 312 that is attached to the interconnecting support bars 308, for example, by immersion coating, adhesive or other bonding methods. The structural framework may be folded into a collapsed delivery configuration in an orderly manner without damaging the film.

Spoke

Still as an example shown in fig. 3A, a wall contact region 309 may be connected by spokes 307 to a coupling element 304 at the proximal end 305 of the device 300. As shown in the figures, in the deployed configuration, the spokes 307 may flare radially from the small diameter coupling element 304 to the large diameter wall contact region 309. In its compressed delivery configuration, the spokes 307 can conduct forces (e.g., axial push-pull or rotational forces) applied to the coupling member 304, such as forces applied to the wall contact area 309 by a delivery tool coupled to the coupling member. The spokes can transmit a resilient force radially outwardly to the wall contact area but do not exert a force sufficient to affect the air-sealing function of the wall contact area. When the device 300 is in its deployed state and the delivery sleeve is advanced over the coupling element 304, the force exerted by the delivery sleeve on the spokes 307 may cause the spokes to contract radially and may compress the wall contact area 309 so that the device may be fully received within the delivery sleeve, or at least the diameter of the wall contact area may be reduced to some extent. This allows the contact force with the airway wall to be removed to assist in repositioning the device. Alternatively, the spokes 307 may comprise a proximal transition portion 314, which may be pre-shaped in a concave configuration or in a configuration at a smaller angle to the coupling element than the other portions of the spokes to the coupling element, so that compression of the device may be assisted by advancing the delivery cannula, wherein it is necessary to first apply a force to the transition portion to begin compressing the spokes. In some embodiments, as shown in fig. 4A, 4B, 4C, and 5A, the

spokes

354, 457, 501 may curve in an "S" shape such that the

coupling elements

356, 458, 502 may be longitudinally adjacent to the

wall contact regions

358, 454, 503, thereby shortening the

overall length

355, 459, 504 of the device in its deployed state.

Valve cover

As an example shown in fig. 4C, an implantable endoscopic valve 480, such as a pulmonary lobe valve, may include a valve cover 479 to wrap or frame a one-way valve 478, and may be made from a structural frame. The valve housing 479 can be located on the structural frame between the spokes 477 and the coupling elements 476.

In another embodiment, as shown in fig. 5A, 5B, and 5C, a device 500 can include a valve cover 505 that can be radially deformed from a collapsed delivery state to a deployed state. As shown in fig. 5A, 5B, and 5C, the deployable valve cover 505 is in a deployed state. Fig. 7A illustrates the device of fig. 5A attached to a delivery rod 540, wherein the coupling element 502 of the device can be intercoupled with the coupling element 542 of the delivery rod. A delivery sleeve 541 may compress the expandable coupling element 502 into its collapsed delivery state, wherein the expandable valve cover has a sized diameter 544 after compression. Fig. 7D illustrates the device 500 and delivery cannula after detachment from the delivery rod, wherein the expandable coupling elements 502 and the valve cover 505 can elastically deform into their unconstrained, deployed state in which the diameter 543 (e.g., a diameter in the range of 3 to 4 millimeters) is greater than the diameter 544 (e.g., a diameter in the range of 2 to 2.8 millimeters as shown in fig. 7A) in the collapsed state.

Coupling element

A leaflet valve can further include a coupling element at the proximal end of the device that can be intercoupled with and disengaged from a coupling element on a delivery rod in response to manipulation by an operator. The coupling element may be part of a structural frame and may be made of laser cut tubing. For example, the coupling element of the leaflet valve may be in a coupled state with the coupling element of the delivery rod when contained in the delivery sleeve and disengaged when the delivery sleeve is withdrawn. An operator may control an operational action (e.g., twisting, triggering, sliding, keying), such as manipulation from a handle associated with the delivery cannula and the delivery rod, may control the relative positions of the delivery rod and cannula, and thus the disengagement of the coupling element. While the radial cinching maintains the longitudinal arrangement of the coupling elements in the delivery sleeve (as shown in fig. 6C), the coupling elements of the device may remain attached to the coupling elements of the delivery rod or may be intercoupled with the coupling elements of the delivery rod while maintaining the expandable coupling elements of the leaflet valve in a cinched delivery state (e.g., fig. 6A). In the connected state, the coupling element can conduct operational behavior from the delivery rod to the implantable valve, including conduction in a longitudinal distal direction, a longitudinal proximal direction, and rotation about a longitudinal axis.

In some embodiments contemplated that include a valve cover, the coupling element can be coupled to the valve cover. For example, as shown in fig. 4C, the coupling element 476 is located directly at the proximal end of the valve housing 479. The coupling element in this concept has a recess 475 cut from the tube structure. The proximal neck 474 of the recess is narrower than the distal flared structure 473 (as shown in figure 4D). The transition 472 from the neck 474 to the distal flared structure 473 can be angled, for example, at an angle to assist in the disengagement and reconnection of the coupling element 476. The length 471 of the coupling element 476 may be in the range of about 0.11 to 0.12 inches (2.8 to 3 millimeters). The distal end of the coupling element may be a tubular portion that is uncut along its circumference and connected to the spokes 477 of the structural frame. The tubular portion may serve as a valve cover 477.

In another example, as shown in fig. 5A, 7A through 7D, the coupling element 502 is directly adjacent to an expandable valve cover 505. The coupling element 502 has a number (e.g., 2 to 10, 8) of coupling ends 506 adapted to be placed into the negative space of the delivery rod coupling element 542 and may be held in a coupled position by a cinch sleeve 541. The end of the coupling end 506 may be rounded to help avoid damage to the airway. Each coupling end 506 may include a neck section 507 at a distal end of the head end 508 that is narrower than the head end and both are sized to fit within the negative space of the neck section 545 and head end 546 of delivery rod coupling element 542 (as shown in fig. 7D). This allows the

coupling elements

542 and 502 to remain locked and the coupling element assembly to translate from the delivery rod to the valve when constrained in the delivery sheath, and to disengage the coupling element assembly when the delivery sheath is withdrawn.

Covering/sealing

The disclosed leaflet valve may further comprise at least one membrane (e.g., 470 in fig. 4C) coupled to the structural frame for creating an air seal in the bronchi of the leaflet, allowing air to flow only, or at least mostly only, through the openings of the membrane, and directing air through the one-way valve 478. The material of the sealing membrane may further prevent tissue ingrowth so that the valve may be safely removed after a period of implantation. The material may be of a type that prevents adhesion to itself, thereby assisting in deforming the valve from the collapsed delivery configuration to the deployed deployment configuration.

Such a membrane attached to the structural frame may be made of a thin, flexible, durable, foldable, or elastic material, such as urethane, polyurethane, ePTFE, silicone, parylene, or a mixture of materials. The film can be formed by insert molding, dip coating or spray coating mold molding, or other methods of manufacturing medical balloons or films. It may be attached to the frame, for example by coating the frame, laminating, dipping, spraying, melting, gluing or sewing on the outside of the frame. As shown in fig. 4C for example, the membrane 470 may cover the wall contact area 469 of the structural frame 468 and at least a portion of the luminal area 466 such that air cannot pass within the bronchial lumen, allowing air to pass only through the one-way valve 478 and preventing air from leaking between the peripheral wall contact area thereof and the airway wall. As shown in fig. 4, a lumen coverage area 466 can be proximal to the wall contact area 469 and the membrane 468 can optionally be attached to the spokes 477. Alternatively, as shown in FIG. 4A, a lumen coverage zone 359 can be distal 353 of the wall contact zone 358. This configuration may also allow the device to seal against gas flow in the event of placement in an irregularly shaped bronchus, or placement out of alignment with the axis of the bronchus.

The sealing membrane may be placed over the internal cavity formed by the structural frame and attached to the inside surface of the structural frame as shown in fig. 5A. Alternatively, the sealing film may be attached to the outside of the structural frame. Alternatively, the sealing membrane may comprise an inner membrane attached to the inner surface of the structural frame and an outer membrane attached to the outer surface of the structural frame, wherein the inner and outer membranes may be connected to each other between the support bars or spokes to seal a portion of the structural frame.

The air flow 181 as shown in fig. 7D may flow from the lobes of the lungs at the distal end of the device 500, through a valve 511, and out of the lungs. The sealing membrane 512 in combination with the one-way valve 511 prevents reverse air flow into the lung lobes. Alternatively, the membrane may form a one-way valve, or the valve may be another separate structure attached to the structural frame or sealing membrane.

The portion of the sealing membrane 512 supported by the interconnecting support strips 510 on the wall contact areas 503 may be flexible and may contain slack to promote an airtight effect by bulging outward and applying contact pressure to the airway wall as the pressure differential increases in the air flowing through the device or apparatus.

The sealing membrane and structural frame, by virtue of which it is the wall contact region, form a continuous contact surface along the circumference of the target airway wall.

In another embodiment of the sealing structure, the sealing structure may include a passage configured to allow air to pass through the sealing structure from either direction during the initial stages of device implantation and may gradually close to block air passage through channels other than through the valve. For example, the passage may be located in the face of the sealing structure immediately adjacent the airway wall and over time (e.g., after several weeks) may become blocked by naturally occurring secretions in the airway. The gradual or delayed sealing action may delay the discharge of trapped air and subsequent lobe volume reduction, thereby allowing the lobe switching action in the treating lung to proceed more gradually, which may reduce the incidence of adverse effects such as pneumothorax or healthy lung tissue damage.

Alternatively, the film may be one that provides a sustained release of a chemical agent over time. For example, the film may deliver a bactericidal, antibacterial or other agent to reduce the risk of infection, pneumonia, rejection reactions or other side effects. For example, the membrane may be impregnated with an antifungal, antibacterial, anti-schizolytic, or anti-inflammatory agent to improve the patient's response to the implanted device.

Valve with a valve body

The device may be used to provide a seal to block airflow, or at least may effectively block air from passing through the target airway via other channels than through the one-way valve. The sealing action may be achieved by attaching a membrane to the structural frame, and the sealing membrane may also form the one-way valve. Alternatively, the valve may be another structure that is attached to the sealing membrane or structural frame. Generally, the valve allows air to flow at least primarily in one direction, from the diseased lung lobes rather than into them. In other words, as shown in fig. 7D, a leaflet valve 500 can restrict the flow 181 from the distal end to the proximal end of the leaflet valve.

Alternatively, the valve material can be impregnated with an antifungal, antibacterial, anti-schizophrenic, or anti-inflammatory agent to improve the patient's response to the implanted device.

For example, shown in FIG. 4D is a cross-sectional view of the device of FIG. 4A, a one-way valve 478 can be made of a flexible, non-blocking elastomeric material, such as urethane, polyurethane, ePTFE, silicone, parylene, or a mixture of materials. The one-way valve 478 can be a duckbill valve comprising a funnel-shaped structure that transitions from a distal flared end to a proximal sealed end. Such a distal flared end may be a tubular form having an outer diameter that is coupled to the lumen-covering region 466 of the sealing membrane 470 and, in certain embodiment concepts, is adapted to be positioned within the valve housing 479. The diameter of the distal flared end may be in the range of 1 to 4 millimeters (e.g., 3 to 4 millimeters). The duckbill valve 478 includes a pair of oppositely positioned and angled wall structures that lip into contact at their distal ends at their proximal sealing ends. The lip structure is connected on both sides and can be pressed flat. The wall structures are movable relative to each other to form an opening for the passage of the fluid when the lip structures are separated. When the wall structures encounter fluid flow in the direction of arrow 181 under cracking pressure, the wall structures separate from one another, forming an opening for fluid flow, as shown in fig. 7D. The lip structure may remain closed when encountering reverse flow fluid and may prevent fluid communication through the duckbill valve. Alternatively, a one-way valve, as is common in the field of other medical devices, may be used. Alternatively, the lip structure may normally be opened at least slightly without a pressure differential across the valve, which may reduce or eliminate cracking pressure and reduce the opening response time.

Fixing mechanism

The valve may have a fixation mechanism such as a dart, a radially compressed structure, or a radially interposed structure. The fixation mechanism may hold the device in a target position in the patient's respiratory tract. The device may be removed by applying a force to the coupling element, overcoming the inherent force of the securing mechanism. Alternatively, the securing mechanism may be disengaged from the airway by compressing the leaflet valve.

Fig. 2 shows a structural frame 242 comprising support bars 249 interconnected in a zigzag pattern around wall contact regions 248. At the distal end 243 of the device, such interconnected support strips may terminate at a junction 250 that may serve to exert an outward contact force against the walls of the target airway, as well as a vector of forces in the distal direction 243. For example, the terminal connection part 250 may be flared outward. Alternatively, the ends of the connection terminals 250 may be rounded ends 251 to increase surface area and reduce the chance of puncturing or injuring the airway wall. The terminal connecting portion 250 and/or the rounded end 251 may be secured by applying frictional and outward radial forces.

The valve 241 includes a coupling element 245, which may be a cylindrical structure 244, including an open portion for mating with a mating coupling element on the delivery rod. The cylindrical structure comprises an annular ring 246 connecting the coupling elements 245 with the spokes 247 and may provide structural support for the spokes.

Fig. 3A to 5C illustrate some other example concepts of a

leaflet valve

300, 260, 300, 350, 450. The lobar valves include radially outward spikes 301, 261, 351, 451,452, 467, 513, 514. As an example in fig. 4C, the leaflet valve 480 includes a structural frame 468 that includes radially extending spurs 467 that can be deployed therewith when the structural frame is deployed. The spurs 467 are part of the structural framework, laser cut from the tubular structure, and pre-shaped to the deployed state. In one embodiment, the spur comprises a non-sharp (e.g., square-cut, rounded) tip and serves as a fixation mechanism by wedging into a groove or uneven surface on the airway wall, such as a groove formed by the cricoid or the cartilage plate, or simply focusing frictional forces on the airway wall. In addition to radial expansion, the spikes may be inclined proximally (e.g., as shown in fig. 4A and 4C) or distally (e.g., as shown in fig. 3A and 3B), or the device may include both proximally and distally directed spikes (e.g., as shown in fig. 4B and 5A) to provide a vector of force against the airway wall to further prevent longitudinal displacement within the airway. Fig. 4B illustrates a leaflet valve embodiment including radially expanding prongs 451, the prongs 452 being integrated into a structural frame 453 crosswise to the distal and proximal portions.

The prongs 451,452 can be positioned at a wall contact area 454 of a leaflet valve 450, which can be at the proximal portion, the distal portion, or somewhere in between, but preferably can be at the distal portion, as the distal portion will first contact the airway wall when deployed from a delivery state.

In the collapsed delivery state, the prongs 451,452 can be retracted and flush with the spokes 457 and the interconnected support bars 460 so that the device can be advanced within a delivery cannula.

The spurs 451,452 can protrude from the wall contact area 454 a distance in the range of 0.25 to 1 mm.

Regardless of the fixation mechanism embodiments, the leaflet valve 450 may be implanted and a test pull may be applied to the device before the delivery tool and bronchoscope are removed to ensure that the device is secured in place. The pulling force may be generated by applying a slight pulling force to the delivery tool when the delivery tool is coupled to the grasping mechanism implanted in the valve. A force gauge may be used to indicate the force applied to the valve. If the valve falls below a predetermined force, the stent fixation mechanism is not suitable for the current implantation situation, requiring another size device, or requiring the device to be repositioned.

Example of the embodiment

Fig. 3A illustrates an example of a lung leaflet valve comprising a structural frame 302 with wall-contacting regions 309 comprising interconnected support strips 308 forming a diamond-shaped lattice. The structural frame 302 includes a coupling element 304 at its proximal portion 305 that is connected to a proximal loop structure 306. Support spokes 307 are connected to the ring structure 306 and extend radially outwardly therefrom. Each support spoke diverges 308 at a wall contact area 309 that contacts the airway wall, converges at a junction 310 at the distal end, and connects to an adjacent branch at a corrugated junction 311. The structures are interconnected at connection points 311 in a diamond-shaped grid 312 and connected at the proximal end to the support spokes 307, with the connection points 310 at the distal end being free ends. The structural frame 302 includes barbs 301 angled radially outward and distally to deploy when the frame is deployed. A sealing membrane 316 is attached to the wall contact area 309 around the structural frame and stretches inwardly to obstruct the lumen coverage area 315 at the distal end of the device where it is attached to the valve 313 contained in the wall contact area 309. This design may provide support for the sealing membrane 316 and may act as a seal between the device and the airway wall, while allowing the sealing membrane between the interconnecting support strips to bulge outward during inhalation (e.g., when the air pressure at the proximal end 305 of the device is higher than at the distal end 303) for additional sealing effects. Such diamond shaped mesh 312 and mesh connection points 311 may also improve the sealing effect between the device and the respiratory tract by preventing folds in the membrane.

Fig. 3B illustrates a lung leaflet valve 260 similar to the device 300 shown in fig. 3A, but with the sealing membrane at the distal end 263 of the lung leaflet valve 260 covering both the proximal cover regions 275 with the membrane covering the spokes 267 and the distal cylindrical structure regions 269 with the membrane covering the struts 268. The sealing membrane may form an air barrier because it includes both a proximal cover region 275 that may effectively block the airway and a distal cylindrical structure region 269 that may form a deployable wall-contacting region 269 that may create a sealing effect with the airway wall. The membrane 276 may continue to form a one-way valve 273, which may be located within and supported by a valve cover 266. The cylindrical valve cover 266 may also form a coupling element 264.

In the leaflet valve 260, the one-way valve 273 and the membrane 276 can be an integral element, such as a plastic laminate structure.

In the leaflet valve 260, the spokes 267 can include spurs 261 that extend outward from the spokes and the deployable wall contact region 269. The structural frame is a mesh structure formed by the proximal support bars 268 and the distal support bars 262 at the junctions 271. The support bar 262 may be rounded or curved at its distal end 270 and may support the distal circumferential edge of the sealing membrane.

Figure 4A illustrates another leaflet valve 350 comprising a structural frame 352 open at a distal end 353. this leaflet valve 350 is similar to the leaflet valve 300 shown in figure 3A, but in the deployed state of the device, the frame 352 comprises spokes 354 that extend radially apart to form an "S" shaped curve as shown, allowing the coupling elements 356 to be closer to the center of the device than the device shown in figure 3A, thereby reducing the overall length 355 of the device. The reduced overall length makes the device more suitable for shorter lobar bronchi and allows for easy expectoration when the device is detached. Such curved support strip spokes 354 may provide greater force to the airway wall than the device shown in fig. 3A. Alternatively, the structural frame may contain the spurs 351 formed by the support spokes 354 (e.g., laser cut). As shown, the spurs 351 are angled outwardly and proximally. Alternatively, as shown in FIG. 4B, the

prongs

452 and 451 extend radially outward from the wall contact area 454 and alternate in different directions. The spur 451 is inclined toward the distal end 455, while the spur 452 is inclined toward the proximal end 456. The alternating spikes may allow the device 450 to be secured in a segment of the lobar bronchus and prevent inward and outward displacement in the respiratory tract, and may further maintain orientation.

The sealing membrane on the leaflet valve 350 may comprise a cylindrical structure 361 attached to the inner surface of the support strip and a one-way valve 360. The sealing membrane may thus form a barrier extending radially inwardly from the support strip 352 to the one-way valve.

Fig. 4C illustrates another leaflet valve 480 similar to the device shown in fig. 4A, but with the valve 478 at the proximal end and supported in a valve housing 479. The membrane 470 is connected to support bars interconnected at wall contact area 469 and spokes 477 at lumen cover area 466 and forms the one-way valve 478. Fig. 4D is a longitudinal sectional view of the device shown in fig. 4C.

Fig. 5A illustrates another embodiment 500 of a leaflet valve, wherein the valve cover 505 is expandable. The valve cover is formed on interconnected support strips that are deformable from a collapsed delivery state to a deployed state when released from the delivery sheath. The one-way valve 511 supported by the valve cover can be made of a flexible film (e.g., an elastomeric material) that conforms to the delivery configuration of the valve cover after compression (e.g., folding) and expands as the valve cover expands. The coupling element 502 may also be expandable. As shown, the spoke 501 is "S" shaped, but may alternatively be a straight spoke 307 as shown in FIG. 3A. The illustrated barbs 513,514 are oriented alternately and are distributed in the middle of the wall contact area 503, but may be other types of barbs as disclosed herein.

Delivery tool

As shown in fig. 6A and 6B, a delivery tool 195 for delivering a leaflet valve (e.g., 480) via a bronchoscope 196 may comprise a delivery rod 197, which may be of a flexible, stretchable, tubular or rod-like structure, and comprising a pre-shaped coupling element 199 at its distal end for coupling with a coupling element (e.g., 476) of the valve, and comprising a delivery sleeve 211 and a handle 198 at its proximal end. For example, the coupling element 199 can be a cut, groove, or a negative direction space that can mate with a positive direction space on the valve coupling element 476. For example, to interact with a coupling element 476 comprising a chamfered neck structure 474, a chamfered flared structure 473, and a transitional angled structure 472, the coupling element 199 may comprise a flared structure 200, a neck structure 201, and a transitional angled structure 202 between the neck structure 201 and the flared structure 200. A delivery rod may be flexible and bendable and may be passed longitudinally through a curved bronchoscope within a curved airway without being stretched, compressed or otherwise buckled so that it can transmit motion from a proximal end (e.g., a handle) to the coupling element 199 and to the valve of the pulmonary lobe. A delivery rod may be made of high polymer and may contain an embedded laser cut tube or compact coil.

In another embodiment, as shown in fig. 6D, a delivery rod 205 can comprise a central lumen 203, which can be used for delivery over a guidewire 204, or for passage or delivery of other devices, such as an endoscope. Alternatively, as shown in fig. 6E, a delivery rod 208 may include a distally extending shaft core 209 that may be used to hold a valve (e.g., 87) in the delivery rod 208, to increase the coupling force, to orient the coupling elements 264 of the valve as it is withdrawn, or to adjust its position.

Alternatively, the delivery tool may comprise a delivery sleeve 211 incorporating the

several delivery rods

197, 205, and 208. As shown in fig. 6B, the sleeve can hold

mating coupling elements

476 and 199 received within the sleeve in a locked state. This mating element combination can be released upon recovery of the cannula, or by advancing the mating coupling element 476 and coupling element 199 out of the cannula. Such

angled transitions

202 and 472 may assist in the release or reattachment of the mating element combination. The sheath can be used to restrain the valve in a delivery state when the valve is in delivery in the working channel, as shown in fig. 6B. The distal portion of the delivery cannula (e.g., about 10 cm from the distal tip) may be relatively more flexible, allowing it to bend or shuttle in a bronchoscope where the distal bend may travel within a tortuous airway. The delivery cannula does not compress or stretch over its entire length. The delivery sleeve is circumferentially non-deformable at least at its distal end so that it may contain a pulmonary lobe valve and be compressed into a collapsed delivery state. A laser cut steel tube may be embedded in a high polymer material, such as Pebax nylon elastomer material, at its distal end portion to provide hoop stress and hoop deformation resistance. The delivery sleeve may be made of a high polymer material, such as Pebax nylon elastomer material or polyimide, braided or wrapped with a metal coil to resist compression, tension or crimping. The delivery cannula 211 may have an outer diameter sized to slidably shuttle within the working channel 194 of the bronchoscope (e.g., an outer diameter in the range of 2 to 2.7 mm may fit into a 2.8 mm cannula). The inner diameter of the sleeve may be in the range of 1.5 to 2.5 mm.

Alternatively, a delivery tool may comprise a pincer-type tool 214 that may be slid through the lumen 217 of the delivery sleeve 216 and may grasp tissue, such as a carina 62, through the opening of the one-way valve on the pulmonary lobe valve, as shown in figure 6F. The pincer-type tool may include pincer structures 215 at its distal end, which may be controlled by a trigger mechanism (not shown) on the handle at the proximal end of the pincer tool. During implantation, the pincer structure 215 may be advanced through the lumen 217 of the delivery sleeve and the valve, for example in a state of constrictive delivery of the valve within the delivery sleeve 218, and the pincer structure may be triggered to grasp tissue, such as the carina of the airway most proximal to the distal end of the bronchi of the lobes of the lungs. A flexible rod 220 connected to the pincer structure 215 can be used as a track to assist in delivering a valve. Fig. 6F omits the membrane and valve to illustrate this structural frame, but it should be understood that the leaflet valve will include a sealing membrane and valve as illustrated in other embodiments. The delivery rod 216 can be advanced relative to the delivery sheath 218 to push the valve out of the sheath to assume a deployed configuration. This action can be accomplished by withdrawing the cannula relative to the pincer-type tool and lung tissue, or advancing the delivery rod while maintaining the position of the cannula relative to the pincer structure, or a combination of these. Alternatively, the delivery rod may be interlocked with the pincer-type tool at the proximal end of the delivery tool, e.g., secured by a collet or set bolt, to ensure the translational position of the valve relative to the pincer-type tool, and thus the valve relative to the pulmonary lobe bronchus, when the pincer structure grasps lung tissue. Thereafter, or the cannula may be withdrawn by a trigger mechanism 212 on the delivery tool (as shown in FIG. 6A).

In another delivery tool embodiment, coupling element 542 of the delivery tool, as shown in fig. 7A, can be mated with a coupling element of an expandable lobular bronchial valve (e.g., 502 on device 500).

Alternatively, the delivery tool may include a handle 198 in the proximal region thereof having a detent (e.g., a thumb push rod) that controls the sliding translational movement of the rod 197 relative to the sleeve 211 to facilitate one-handed operation in delivering or retracting the valve from the sleeve. For example, a sleeve 211 may be coupled to the handle body and a rod 197 may be slidably engaged in the sleeve and coupled to a movable (e.g., rotating or translating) actuator in the handle and may be moved by an engagement actuator coupled to an actuator, such as a thumb push, slider or knob. The handle may contain one or more triggers that can move the delivery rod and control the position of the leaflet valve from a fully contained position, as shown in fig. 7B, to a partially deployed position, as shown in fig. 7C, when the coupling elements are connected, to a fully deployed and disengaged position, as shown in fig. 7D. For example, a delivery tool 195 and a leaflet valve 500 can be placed in sterile packaging with the delivery rod 540 in a first position (state 1), the coupling elements 542,502 remaining interlocked, and the device 500 deployed as part of fig. 7A. The first trigger may be used to deliver and retrieve the device, partially deployed. By this step, the location and suitability within the target airway can be assessed when viewed through the lens 193 of the bronchoscope 196. The first trigger may stop control at the state 1 position before completely disengaging the device. A second trigger, such as a trigger, may be used to fully retract the delivery cannula or to unlock the first trigger from state 1 for further delivery and to disengage the device 500 (fig. 7D). The first and second triggers may be ergonomically arranged on the handle 198 for single-handed operation, e.g., the first trigger may be located in the thumb operating region and the second trigger may be located in the index finger operating region of the same hand. Alternatively, the delivery cannula and delivery rod may be coupled to a rotary trigger on the handle that is rotationally operated while maintaining the handle in a comfortable position for the operator's hand.

Suit set

Alternatively, the valve can be preloaded in its collapsed delivery state in a (also disposable) delivery sleeve and coupled to a delivery rod as shown in fig. 6B. Alternatively, a leaflet valve can be coupled with the delivery rod within the delivery sheath, but the remainder of the leaflet valve is in an unconstrained state outside the delivery sheath, as shown in fig. 7A. The assembled structure may be stored in a sterile package with instructions for use. The lobe valve in a partially deployed state may assist in monitoring and avoid material deformation due to long term constraint.

Delivery of

A method may include the following delivery steps:

determining the position of the implanted valve, the size and the length of the target respiratory tract according to CT scanning measurement;

visually inspecting a leaflet valve coupled in the delivery system (see fig. 7A);

delivering a bronchoscope to a target lobar bronchus through an endotracheal tube of a patient;

retracting the leaflet valve within the delivery cannula and delivering the preloaded leaflet valve delivery system forward through the working channel of the bronchoscope;

pushing the distal end of the delivery system out from the distal end of the working channel to the desired valve location of the target airway (fig. 7B);

while maintaining the relative position of the bronchoscope and the airway, withdrawing the delivery sleeve from the proximal end relative to the leaflet valve, leaving the valve in a deployed but still coupled state (state 1, fig. 7C);

the position, and the moderation, alignment orientation and sealing effect are monitored by the lens of the bronchoscope. Confirming the mechanical fixation and cooperation effect of the valve and the wall of the respiratory tract by slightly pulling the delivery system;

indicating that the valve of the lung lobe has blocked the airway by confirming cessation of respiratory motion within the airway;

if the position, and the degree, the alignment orientation, the sealing effect and the fixing effect are not ideal, the delivery system can be adjusted by pushing and pulling;

if the position, and adequacy, alignment, sealing and fixation are still not ideal, the leaflet valve can be withdrawn into the delivery sheath;

repositioning the delivery cannula and the leaflet valve;

if the position, and the degree, alignment, sealing effect and fixation effect are desired, the delivery sheath is retracted to the state 2 position, thereby fully deploying the leaflet valve and disengaging the coupling element of the valve from the coupling element of the delivery system;

removing the delivery system;

detecting the valve of the lung lobe through a lens of the bronchoscope;

the bronchoscope is removed.

Although at least one exemplary embodiment of this invention has been disclosed herein, it should be understood that any modifications, substitutions, and alternatives to those skilled in the art will be apparent, and may be made without departing from the scope of the invention. The disclosed invention is intended to cover any modified or varied embodiments of the exemplary embodiments. In addition, in the present invention, the term "comprising" does not include other elements or steps, the term "a/one" does not include a plurality of numbers, and the term "or" means either or both. Furthermore, features or steps described in the present disclosure may be combined with other features or steps and occur in any order, unless the present disclosure or the context indicates otherwise. The entire disclosure of a patent or application claiming benefit of priority is hereby incorporated by reference into this specification.

Claims

1. A bronchial access flow control device (241, 260, 300, 350, 450, 480, 500) comprising:

a one-way valve (273, 313, 360, 478, 511);

a hollow structural frame (242, 302, 353, 453, 468, 509) comprising the one-way valve, wherein said structural frame is expandable from a compressed state to an expanded state, and

a sealing membrane (316, 470, 512) is mounted at least at the distal end of the structural frame, wherein said sealing membrane may form a closure wall which may form at least part of the airflow passage through the flow control device, and the one-way valve may be contained in the airflow passage.

2. The flow control device (241, 260, 300, 350, 450, 480, 500) of claim 1 further comprising a plurality of prongs (261, 301, 351, 451, 452) extending radially outward from the structural frame in the deployed configuration.

3. A flow control device (241, 260, 300, 350, 450, 480, 500) according to claim 2, wherein the spikes (261, 301, 351, 451, 452) extend at an acute angle to the longitudinal axis of the flow control device.

4. A flow control device (241, 260, 300, 350, 450, 480, 500) as claimed in claims 2, 3, some of which said spikes (451, 514) are inclined towards the distal end of the flow control device and others (452, 513) are inclined towards the proximal end of the flow control device.

5. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 2 to 4, wherein at least a portion of the spurs (261, 301, 351, 451, 452) extend from spokes (247, 267, 307, 354, 457, 477, 501) in the hollow structural frame (242, 302, 353, 453, 468, 509).

6. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 2 to 5, wherein said at least part of the spur (513, 514) extends from the middle of the hollow structural frame (242, 302, 353, 453, 468, 509).

7. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 2 to 5, wherein said at least part of the spurs (513, 514) extend from a cylindrical structure (269, 309, 358, 454, 469, 503) of the hollow structural frame (242, 302, 352, 453, 468, 509), wherein said cylindrical structure is at a distal end of the flow control device.

8. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any of claims 1 to 7, wherein the width of the hollow structural frame in the deployed configuration is in the range 7 to 12 mm, or in the range 5 to 15 mm, or in the range 11 to 14 mm.

9. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 1 to 8, wherein the length of the flow control device in the deployed configuration is in the range 5 to 15 mm.

10. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 1 to 9, wherein the hollow structural frame (242, 302, 352, 453, 468, 509) in the deployed configuration comprises a cylindrical structure (269, 309, 358, 454, 469, 503) at its distal end.

11. A flow control device (241, 260, 300, 350, 450, 480, 500) according to claim 10, wherein said sealing membrane (316, 470, 512) is attached to the cylindrical structure (269, 309, 358, 454, 469, 503).

12. A flow control device (241, 260, 300, 350, 450, 480, 500) according to claim 10, wherein said sealing membrane (316, 470, 512) covers the cylindrical structure (269, 309, 358, 454, 469, 503) and the spokes (247, 267, 307, 354, 457, 477, 501) within the structural frame.

13. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 1 to 12, wherein the hollow structural frame (242, 302, 352, 453, 468, 509) in its compressed form has a diameter of no more than 2.6 mm.

14. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 1 to 13, wherein the hollow structural frame (242, 302, 352, 453, 468, 509) in its compressed form has a diameter in the range of 2 to 2.6 mm.

15. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any of claims 1 to 14, wherein the hollow structural frame (242, 302, 352, 453, 468, 509) in its deployed configuration has an aspect ratio in the range 0.28:1 to 0.54:1, such as about 0.417: 1.

16. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 1 to 14, wherein the hollow structural frame (242, 302, 352, 453, 468, 509) has a ratio of its width in its expanded configuration to its width in its compressed configuration in the range 4:1 to 7:1, such as about 5.45: 1.

17. A flow control device (241, 260, 300, 350, 450, 480, 500) according to any one of claims 1 to 16, wherein said flow control device comprises a coupling element (245, 264, 304, 356, 476, 502) at a proximal end thereof.

18. The flow control device (241, 260, 300, 350, 450, 480, 500) of any one of claims 1 to 17, wherein said flow control device comprises a coupling element (245, 264, 304, 356, 476, 502) at a proximal end thereof and which couples with a corresponding coupling element (199, 542) on a delivery device stem structure (208, 540).

19. The flow control device (241, 260, 300, 350, 450, 480, 500) of claim 18, wherein said coupling element is made of a laser cut tube and forms a proximal portion of the flow control device.

20. A flow control device (241, 260, 300, 350, 450, 480, 500) according to claim 19, wherein said laser cut tube wall thickness is in the range of 0.11 to 0.17 mm.

21. The flow control device (500) according to claim 19, wherein said coupling element (502) comprises a plurality of coupling ends (508), each coupling end unit (506) being connected to the neck structure (507), and wherein said coupling element (502) is deformable from a collapsed delivery state to an expanded state.

22. The flow control device (500) as claimed in claim 21, wherein said coupling end unit (506) may form a deployable valve cover 505 enclosing a one-way valve 511.

23. An air flow control device and assembly device for a bronchial passage insertion tool includes:

an air flow control device (241, 260, 300, 350, 450, 480, 500), wherein each of said air flow control devices comprises:

a one-way valve (273, 313, 360, 478, 511);

a hollow structural frame (242, 302, 352, 453, 468, 509) comprising the one-way valve, wherein said structural frame is expandable from a compressed state to an expanded state;

a sealing membrane (316, 470, 512) is mounted at least at a distal end of the structural frame, wherein said sealing membrane may form at least a portion of an airflow passage through the flow control device, and the one-way valve may be contained in the airflow passage, and further comprising

A first coupling element (245, 264, 304, 356, 476, 502) located at a proximal end of the flow control device;

a delivery cannula (211) positionable within a bronchial passage, wherein said delivery cannula comprises a distal portion, wherein said air flow control device is in its compressed configuration within the delivery cannula;

a delivery rod (208) within the delivery cannula, extendable distally through the delivery cannula; and comprises

A second coupling element (199, 542) at the distal end of the delivery sheath, wherein said second coupling element is adapted to mate with the first coupling element when the air flow control device is at least partially disposed within the delivery sheath,

wherein said delivery rod (208) is advanceable through the delivery sheath to advance the flow control device from the distal end of the delivery sheath into the bronchial passage, and

the airflow control device may be automatically disengaged from the second coupling element and expanded from the compressed configuration to the expanded configuration after being pushed out of the delivery cannula.

24. An air flow control device and assembly device for a bronchial passage insertion tool in accordance with claim 23, further comprising a spindle wire (209) within the delivery rod, wherein said spindle wire may extend from the distal end of the delivery rod and serve to ensure a tight fit between the first and second coupling elements.